Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000545763
Ethics application status
Approved
Date submitted
23/03/2022
Date registered
7/04/2022
Date last updated
7/07/2023
Date data sharing statement initially provided
7/04/2022
Date results information initially provided
14/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase 1 study assessing the safety and tolerability of MTx-COVAB36 in healthy volunteers.
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] 306407 0
MTx-COVAB36-AU-1.02CoV
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 325242 0
Condition category
Condition code
Respiratory 322640 322640 0 0
Other respiratory disorders / diseases
Infection 322641 322641 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single blind, placebo-controlled clinical trial designed to determine the safety and tolerability of MTx-COVAB36 after a single administration in a dose escalation, dose limiting toxicity (DLT)-driven approach in healthy volunteers. Additional data to define the recommended phase II dose (RP2D) will also be determined.

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.

The trial will comprise four dose cohorts, each composed of 6 participants receiving MTx-COVAB36 and 2 participants receiving placebo via intravenous infusion, with pre-defined dose levels. The pre-defined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be administered a single dose of either IMP or placebo on Day 1 of the study and will be followed up until 63 days post administration.
Intervention code [1] 322837 0
Treatment: Drugs
Comparator / control treatment
Participants randomised to receive Placebo (0.9% NaCl) via intravenous infusion, will be dosed on Day 1 and followed up until 63 days post administration.
Control group
Placebo

Outcomes
Primary outcome [1] 330590 0
To evaluate the safety and tolerability of single ascending doses of MTx-COVAB36 administered intravenously to healthy volunteers and bring additional data to define the recommended phase II dose (RP2D). Done by assessing the incidence, severity and causal relationship of adverse events following single dose intravenous (IV) administration of MTx-COVAB36 to healthy volunteers will be assessed.

As this is the first time MTx-COVAB36 is being studied in humans, there is limited information on the possible side effects or adverse reactions. Safety and tolerability will be assessed by clinical review of the following parameters:
- Adverse events (assessed using the Common Terminology Criteria for Adverse Events (CTCAE4)
- Vital signs (assessment of heart rate, blood pressure and body temperature)
- 12 lead ECG
- Hematology, chemistry, urinalysis (assessed using blood and urine samples)
- Physical examination (general appearance, HEENT, lymphatic, dermatological, musculoskeletal, cardiovascular, respiratory, gastrointestinal and neurological)
Timepoint [1] 330590 0
Assessed everyday from Day 1 (IMP administration day) to Day 63 (Final visit)
Secondary outcome [1] 406852 0
To describe the pharmacokinetics of MTx-COVAB36 in healthy volunteers after single dose intravenous administration.

Estimation of the following pharmacokinetics (PK) parameters post administration of a single dose of MTx-COVAB36 participants using blood samples:
• Maximum serum concentration (Cmax)
• Time to Cmax (Tmax)
• Area under the concentration-time curve from time zero
to the last quantifiable time point (AUC0-t)
• Area under the concentration-time curve from time zero
to infinity (AUC0-inf)
• Apparent clearance (CL/F)
• Apparent volume of distribution (Vd/F)
•Terminal half-life (t1/2)
Timepoint [1] 406852 0
Blood sampling for PK analysis will be performed at scheduled time points: Day 1 (before and 1 (+/-10 min), 2 (+/-10 min), 6 (+/-30min) and 12 hours (+/-30min) after start of IMP administration), and on Day 2, 4, 8, 29, 63.
Secondary outcome [2] 406853 0
To describe the incidence and intensity of anti-drug antibody (ADA), including drug neutralising antibodies (Nab) production following single dose administration of MTx-COVAB36 to healthy volunteers. Blood samples will be collected to assess:
• The proportion of participants producing ADAs and Nabs after administration of a single dose of MTx-COVAB36.
• Concentration of ADAs and Nabs in participants after administration of a single dose of MTx-COVAB36.
Timepoint [2] 406853 0
Assessed on 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) of 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 interview 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 greater than or equal to 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) less than 90 or greater than 150 mmHg, diastolic blood pressure (DBP) less than 40 or greater than 90 mmHg, heart rate (HR) less than 40 or greater than 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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Safety
Statistical methods / analysis
As this is a descriptive First in Human Study to evaluate safety and pharmacokinetics of MTx-COVAB36, no formal sample size calculation is needed.
The general analytical approach for all endpoints will be descriptive in nature. Unless otherwise stated, the following statistical approaches will be taken:

Continuous variables:
Descriptive statistics will include the number of non missing values, mean, standard deviation (SD), median, minimum, and maximum. The minimum and maximum values will be presented to the same number of decimal places as recorded in the raw data; mean, median, and SD will be presented to one more decimal place than the raw data. Geometric mean and coefficient of variation (CV) will also be provided for pharmacokinetic data.

Categorical variables:
Descriptive statistics will include frequency counts and percentages per category. Percentages will be rounded to one decimal place, with the denominator being the number of participants in the relevant population with non missing data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/04/2022
Actual
26/04/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
28/06/2022
Date of last data collection
Anticipated
4/09/2022
Actual
4/09/2022
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21843 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 36901 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 310758 0
Commercial sector/Industry
Name [1] 310758 0
Memo Therapeutics AG
Country [1] 310758 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Memo Therapeutics AG
Address
Wagistr. 27, 8952 Schlieren
Country
Switzerland
Secondary sponsor category [1] 312148 0
Commercial sector/Industry
Name [1] 312148 0
Accelagen Pty Ltd
Address [1] 312148 0
Suite 1.02, Level 1
722 High Street, Kew East
Victoria, 3102
Country [1] 312148 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310336 0
Bellberry Limited
Ethics committee address [1] 310336 0
123 Glen Osmond Rd,
Eastwood. SA 5063
Ethics committee country [1] 310336 0
Australia
Date submitted for ethics approval [1] 310336 0
28/02/2022
Approval date [1] 310336 0
23/03/2022
Ethics approval number [1] 310336 0

Summary
Brief summary
This is a single blind, placebo-controlled clinical trial to determine the safety and tolerability and to gather additional data to define the recommended phase II dose (RP2D) of MTx-COVAB36 after single administration in a dose escalation, dose limiting toxicity (DLT)-driven approach in healthy volunteers.

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. It is indicated for the treatment of patients with mild to moderate COVID-19 disease and with high risk for progression to severe disease.

The trial will comprise four dose cohorts, each composed of 6 participants receiving MTx-COVAB36 and 2 participants receiving placebo, with pre-defined dose levels. The pre-defined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be administered a single dose of either IMP or placebo on Day 1 of the study and will be followed up until 63 days post administration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117282 0
Dr Sam Salman
Address 117282 0
Linear Clinical Research
1 Hospital Avenue, B-Block
Nedlands 6009, WA
Country 117282 0
Australia
Phone 117282 0
+61 86382 5100
Fax 117282 0
Email 117282 0
ssalman@linear.org.au
Contact person for public queries
Name 117283 0
Mr Greg Plunkett
Address 117283 0
Accelagen Pty Ltd
Suite 1.02, Level 1
722 High St, Kew East VIC 3102
Country 117283 0
Australia
Phone 117283 0
+61 3 9114 2274
Fax 117283 0
Email 117283 0
greg.plunkett@accelagen.com.au
Contact person for scientific queries
Name 117284 0
Dr Sam Salman
Address 117284 0
Linear Clinical Research
1 Hospital Avenue, B-Block
Nedlands 6009, WA
Country 117284 0
Australia
Phone 117284 0
+61 86382 5100
Fax 117284 0
Email 117284 0
ssalman@linear.org.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.