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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05351437




Registration number
NCT05351437
Ethics application status
Date submitted
28/03/2022
Date registered
28/04/2022

Titles & IDs
Public title
To Assess the Safety and Tolerability of MTx-COVAB36 as a Therapeutic and Prophylactic Treatment Against COVID-19.
Scientific title
A Phase l, Single-blind, Placebo-controlled Trial Designed to Assess the Safety and Tolerability of a Single Intravenous Dose of MTx-COVAB36 in Healthy Volunteers.
Secondary ID [1] 0 0
MTx-COVAB36-AU-1.02CoV
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MTx-COVAB36
Treatment: Drugs - Placebo

Active comparator: MTx-COVAB36 - Cohort 1 - 100 mg IV dose Cohort 2 - 500 mg IV dose Cohort 3 - 1000 mg IV dose Cohort 4 - 2000 mg IV dose MTx-COVAB36 will be administered as a single dose intravenously.

Placebo comparator: Placebo - Placebo (0.9% NaCl) will be administered as a single dose intravenously.


Treatment: Drugs: MTx-COVAB36
MTx-COVAB36 is a fully human monoclonal IgG1 antibody derived from the memory B cells of convalescent COVID-19 donors and directed against SARS-CoV-2 spike protein with potent virus neutralising activity.

Treatment: Drugs: Placebo
0.9% saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timepoint [1] 0 0
Day 1 (IMP administration day) to Day 63 (Final visit)
Secondary outcome [1] 0 0
Pharmacokinetics measured by the maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Day 1 (IMP administration day) to Day 63 (Final visit)
Secondary outcome [2] 0 0
Pharmacokinetics measured by the area under the concentration-time curve (AUC)
Timepoint [2] 0 0
Day 1 (IMP administration day) to Day 63 (Final visit)
Secondary outcome [3] 0 0
Pharmacokinetics measured by the apparent clearance (CL)
Timepoint [3] 0 0
Day 1 (IMP administration day) to Day 63 (Final visit)
Secondary outcome [4] 0 0
Pharmacokinetics measured by the terminal half-life (t1/2)
Timepoint [4] 0 0
Day 1 (IMP administration day) to Day 63 (Final visit)
Secondary outcome [5] 0 0
Immunogenicity measured by anti-drug antibody (ADA) production
Timepoint [5] 0 0
Day 1 (IMP administration day), Day 8 and Day 29 post-administration and at Day 63 (final visit).
Secondary outcome [6] 0 0
Immunogenicity measured by drug neutralizing antibody (Nab) production
Timepoint [6] 0 0
Day 1 (IMP administration day), Day 8 and Day 29 post-administration and at Day 63 (final visit).

Eligibility
Key inclusion criteria
1. Healthy male or female participants aged 18 years to 50 years at the time of consent
2. Ability to read, understand and provide written informed consent
3. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
4. Healthy participants as established by medical history, laboratory examination, physical examination, vital signs, and ECG during screening and as per the clinical judgment of the investigator
5. Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive)
6. For Woman of Childbearing Potential (WOCBP): agrees to practice true abstinence or agrees to use a highly effective method of contraception consistently from 30 days prior to Day 1 until end of the study (Day 63). Highly effective contraception includes hormonal contraception, placement of intrauterine device (IUD) or intrauterine system (IUS), or a vasectomized partner (performed at least 6 months prior to her screening) who has been documented to no longer produce sperm. Verbal confirmation from the participant through medical interview is acceptable. No contraception requirements for participants in exclusive same-sex relationship.
7. For male participant: must agree to practice true abstinence or use condom if he has a partner of childbearing potential, or must be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm. Verbal confirmation through medical nterview is acceptable). Participant to practice abstinence (if applicable) or use condom until end of the study (Day 63). No contraception requirements for participants in exclusive same-sex relationship.
8. Accessible veins in the forearms for venepuncture and/or intravenous cannulation
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participant with active SARS-CoV-2 infection, verified by RT-PCR test
2. Participants tested positive for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus (HBsAg screen) or Hepatitis C virus (HCV antibody screen)
3. History of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation
4. History of any reaction to monoclonal antibodies
5. History of clinically relevant atopic diseases and/or known allergies to the trial product or its components
6. History of any major pulmonary, cardiovascular, renal, neurological (e.g., cerebrovascular events), metabolic, gastrointestinal, hepato-biliary, or hematological functional abnormality, malignancy (except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin), or mental disability as per discretion of the investigator
7. Any clinically significant laboratory findings at screening and enrolment and at Day-1; one retest is allowed at screening and/or at Day-1
8. Acute illness (moderate or severe) and/or fever (body temperature = 38 °C) during the 72 hours prior to planned study drug application
9. Participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder
10. Receipt of immunoglobulin or blood products within 6 months prior to enrolment
11. Receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer
12. Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study
13. Receipt of any standard vaccine within 14 days prior to Day 1
14. History of alcoholism or drug addiction (as per DSM-V) within 1 year prior to screening
15. Use of prescription drugs within 7 days prior to Day 1 or for 5 half-lives whichever is longer, or during the study, except for hormonal contraceptives or positive result in urine drug screen or alcohol breath test at screening or Day-1
16. Use of over-the-counter medication within 7 days prior to Day 1 or during the study; medication such as paracetamol and ibuprofen may be permitted at the discretion of the investigator and sponsor
17. Receipt of immunosuppressive medications within 6 months prior to enrolment, or any active or prior history of immunodeficiency (receipt of any course of systemic corticosteroids for more than a 7-day duration and with a prednisolone equivalent dose of more than 5 mg per day within 6 months prior to enrolment will exclude a participant; inhaled or topical steroids are allowed)
18. Pregnant, lactating, or planned pregnancy during the study period
19. Inability to comply with the study protocol in the opinion of the investigator
20. Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled
21. Concurrent participation in another interventional clinical study investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the study drug administration or during the course of the study
22. Abnormal vital signs including systolic blood pressure (SBP) < 90 or > 150 mmHg, diastolic blood pressure (DBP) < 40 or > 90 mmHg, heart rate (HR) < 40 or > 100 bpm (average of triplicate measurements) at screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2022
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Memo Therapeutics AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The Sponsor, will not be sharing data with anyone outside of Vakzine Projekt Management (VPM GmbH) and the CRO (Accelagen) involved in the study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05351437