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    Summary
    EudraCT Number: 2020-001038-36
    Sponsor's Protocol Code Number: BNT162-01
    National Competent Authority: Germany - PEI
    Clinical Trial Type: EEA CTA
    Trial Status: Ongoing
    Date on which this record was first entered in the EudraCT database: 2020-04-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1 Member State Concerned Germany - PEI
    A.2 EudraCT number 2020-001038-36
    A.3 Full title of the trial
    A Multi-site Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults
    A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the safety and effects of vaccines in healthy adults.
    A.3.2 Name or abbreviated title of the trial where available
    Phase I/II Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019
    A.4.1 Sponsor's protocol code number BNT162-01
    A.5.3 WHO Universal Trial Reference Number (UTRN) U1111-1249-4220
    A.7 Trial is part of a Paediatric Investigation Plan No
    A.8 EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1 Name of Sponsor BioNTech RNA Pharmaceuticals GmbH
    B.1.3.4 Country Germany
    B.3.1 and B.3.2 Status of the sponsor Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1 Name of organisation providing support BioNTech RNA Pharmaceuticals GmbH
    B.4.2 Country Germany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1 Name of organisation BioNTech RNA Pharmaceuticals GmbH
    B.5.2 Functional name of contact point Clinical Study Management
    B.5.3 Address:
    B.5.3.1 Street Address An der Goldgrube 12
    B.5.3.2 Town/ city Mainz
    B.5.3.3 Post code 55131
    B.5.3.4 Country Germany
    B.5.4 Telephone number 0049613190841204
    B.5.5 Fax number 004961319084392010
    B.5.6 E-mail David.Langer@BioNTech.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3 IMP Role Test
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation No
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name BNT162a1
    D.3.2 Product code RBL063.3
    D.3.4 Pharmaceutical form Concentrate for solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product Yes
    D.3.11.10 Medicinal product containing genetically modified organisms No
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3 IMP Role Test
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation No
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name BNT162b1
    D.3.2 Product code RBP020.3
    D.3.4 Pharmaceutical form Concentrate for solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product Yes
    D.3.11.10 Medicinal product containing genetically modified organisms No
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3 IMP Role Test
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation No
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name BNT162b2
    D.3.2 Product code RBP020.2
    D.3.4 Pharmaceutical form Concentrate for solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product Yes
    D.3.11.10 Medicinal product containing genetically modified organisms No
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3 IMP Role Test
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation No
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name BNT162c2
    D.3.2 Product code RBS004.2
    D.3.4 Pharmaceutical form Concentrate for solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product Yes
    D.3.11.10 Medicinal product containing genetically modified organisms No
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1 Medical condition(s) being investigated
    Protection against COVID-2019
    E.1.1.1 Medical condition in easily understood language
    Healthy volunteers (prevention of infection with the Corona virus)
    E.1.1.2 Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2 Version 20.0
    E.1.2 Level LLT
    E.1.2 Classification code 10051905
    E.1.2 Term Coronavirus infection
    E.1.2 System Organ Class 100000004862
    E.1.3 Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1 Main objective of the trial
    To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after single dose (SD; prime only) or prime/boost (P/B) immunization
    E.2.2 Secondary objectives of the trial
    To describe the immune response in healthy adults after SD or P/B immunization measured by a functional antibody titer, e.g., virus neutralization assay or an equivalent assay available by the time of trial conduct.
    E.2.3 Trial contains a sub-study No
    E.3 Principal inclusion criteria
    1. Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
    2. They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial.
    3. They must be able to understand and follow trial-related instructions.
    4. They must be aged from 18 to 55 years, have a body mass index over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
    5. They must be healthy based on medical history, physical examination, 12-lead ECG, vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at Visit 0.
    6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential.
    7. WOCBP must agree to practice two highly effective forms of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
    8. WOCBP must confirm that they practiced at least one highly effective form of contraception for the 14 d prior to Visit 0.
    9. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
    10. Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
    11. Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
    12. They must have confirmation of their health insurance coverage prior to Visit 0.
    13. They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 d after receiving the last immunization.
    E.4 Principal exclusion criteria
    1. Have had any acute illness, as determined by the investigator, with or without fever, within 72 h prior to the first immunization. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
    2. Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization.
    3. Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
    4. Had any medical condition or any major surgery (e.g., requiring general anesthesia) within the past 5 years which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
    5. Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization.
    6. Had any chronic use (more than 14 continuous days) of any systemic medications, including immunosuppressant or other immune-modifying drugs, within the 6 months prior to Visit 0 unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise subject safety.
    7. Received any vaccination within the 28 d prior to Visit 0.
    8. Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0.
    9. Had administration of another investigational product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0.
    10. Have a known history or a positive test of any of HIV 1 or 2, Hepatitis B, or Hepatitis C, within the 30 d prior to Visit 0.
    11. Have a positive PCR-based test for SARS-CoV-2 within the 30 d prior to Visit 0.
    12. Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or Visit 1.
    13. Have a positive breath alcohol test at Visit 0 or Visit 1.
    14. Previously participated in an investigational trial involving lipid nanoparticles.
    15. Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial.
    16. Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site).
    17. Have a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
    18. Have a history of hypersensitivity or serious reactions to previous vaccinations.
    19. Have a history of Guillain-Barré Syndrome within 6 wks following a previous vaccination.
    20. Have a history of narcolepsy.
    21. Have history of alcohol abuse or drug addiction within 1 year before Visit 0.
    22. Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0.
    23. Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site.
    24. Have had any blood loss >450 mL, e.g., due to donation of blood or blood products or injury, within the 7 d prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 d after receiving the last immunization.
    25. Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties.
    26. Have had contact with persons diagnosed with COVID-19 or who tested positive for SARS-CoV-2 by any diagnostic test within the 30 d prior to Visit 1.
    27. Are soldiers, subjects in detention, CRO or sponsor staff or their family members.
    E.5 End points
    E.5.1 Primary end point(s)
    Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 d after each immunization.
    Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 d after each immunization.
    The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):

    For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 21±2 d after the prime immunization and 28±4 d after the boost immunization.

    For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 d after the immunization.
    E.5.1.1 Timepoint(s) of evaluation of this end point
    see Clinical Trial Protocol, Section 9.4.2 Primary endpoints
    E.5.2 Secondary end point(s)
    For BNT162a1, BNT162b1, BNT162b2 (P/B):
    Functional antibody responses at 7±1 d and 21±2 d after primary immunization and at 21±2 d, 63±5 d, and 162±7 d after the boost immunization.
    Fold increase in functional antibody titers 7±1 d and 21±2 d after primary immunization and at 21±2 d, 63±5 d, and 162±7 d after the boost immunization.
    Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 d and 21±2 d after primary immunization and at 21±2 d, 63±5 d, and 162±7 d after the boost immunization.
    For BNT162c2 (SD):
    Functional antibody responses at 7±1 d, 21±2 d, 42±3 d, 84±5 d, and 183±7 d after the primary immunization.
    Fold increase in functional antibody titers at 7±1 d, 21±2 d, 42±3 d, 84±5 d, and 183±7 d after the primary immunization.
    Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 d, 21±2 d, 42±3 d, 84±5 d, and 183±7 d after the primary immunization.
    E.5.2.1 Timepoint(s) of evaluation of this end point
    see Clinical Trial Protocol, Section 9.4.3 Secondary endpoints
    E.6 and E.7 Scope of the trial
    E.6 Scope of the trial
    E.6.1 Diagnosis No
    E.6.2 Prophylaxis No
    E.6.3 Therapy No
    E.6.4 Safety Yes
    E.6.5 Efficacy No
    E.6.6 Pharmacokinetic No
    E.6.7 Pharmacodynamic No
    E.6.8 Bioequivalence No
    E.6.9 Dose response No
    E.6.10 Pharmacogenetic No
    E.6.11 Pharmacogenomic No
    E.6.12 Pharmacoeconomic No
    E.6.13 Others Yes
    E.6.13.1 Other scope of the trial description
    Tolerability and Immunogenicity
    E.7 Trial type and phase
    E.7.1 Human pharmacology (Phase I) Yes
    E.7.1.1 First administration to humans Yes
    E.7.1.2 Bioequivalence study No
    E.7.1.3 Other Yes
    E.7.1.3.1 Other trial type description
    Phase I/II, 2-Part, Dose-Escalation Trial
    E.7.2 Therapeutic exploratory (Phase II) Yes
    E.7.3 Therapeutic confirmatory (Phase III) No
    E.7.4 Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1 Controlled No
    E.8.1.1 Randomised No
    E.8.1.2 Open Yes
    E.8.1.3 Single blind No
    E.8.1.4 Double blind No
    E.8.1.5 Parallel group Yes
    E.8.1.6 Cross over No
    E.8.1.7 Other Yes
    E.8.1.7.1 Other trial design description
    Part A: dose-escalation design and Part B: parallel cohorts
    E.8.2 Comparator of controlled trial
    E.8.2.1 Other medicinal product(s) No
    E.8.2.2 Placebo No
    E.8.2.3 Other No
    E.8.2.4 Number of treatment arms in the trial 4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1 Number of sites anticipated in Member State concerned 2
    E.8.5 The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1 Trial being conducted both within and outside the EEA No
    E.8.6.2 Trial being conducted completely outside of the EEA No
    E.8.7 Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit (LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1 In the Member State concerned years
    E.8.9.1 In the Member State concerned months 12
    E.8.9.1 In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1 Trial has subjects under 18 No
    F.1.1.1 In Utero No
    F.1.1.2 Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3 Newborns (0-27 days) No
    F.1.1.4 Infants and toddlers (28 days-23 months) No
    F.1.1.5 Children (2-11years) No
    F.1.1.6 Adolescents (12-17 years) No
    F.1.2 Adults (18-64 years) Yes
    F.1.2.1 Number of subjects for this age range: 196
    F.1.3 Elderly (>=65 years) No
    F.2 Gender
    F.2.1 Female Yes
    F.2.2 Male Yes
    F.3 Group of trial subjects
    F.3.1 Healthy volunteers Yes
    F.3.2 Patients No
    F.3.3 Specific vulnerable populations No
    F.3.3.1 Women of childbearing potential not using contraception No
    F.3.3.2 Women of child-bearing potential using contraception Yes
    F.3.3.3 Pregnant women No
    F.3.3.4 Nursing women No
    F.3.3.5 Emergency situation No
    F.3.3.6 Subjects incapable of giving consent personally No
    F.3.3.7 Others No
    F.4 Planned number of subjects to be included
    F.4.1 In the member state 196
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No plans since healthy subjects
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N. Competent Authority Decision Authorised
    N. Date of Competent Authority Decision 2020-04-20
    N. Ethics Committee Opinion of the trial application Favourable
    N. Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N. Date of Ethics Committee Opinion 2020-04-15
    P. End of Trial
    P. End of Trial Status Ongoing
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