SARS-CoV-2 InfectionPhase 1NCT05351437
To Assess the Safety and Tolerability of MTx-COVAB36 as a Therapeutic and Prophylactic Treatment Against COVID-19.
A Phase 1 study testing MTx-COVAB36 in people with SARS-CoV-2 Infection, run by Memo Therapeutics AG at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- MTx-COVAB36
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Apr 2022to 2 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants aged 18 years to 50 years at the time of consent
- Ability to read, understand and provide written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- 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
- Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive)
- 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.
- 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.
- Accessible veins in the forearms for venepuncture and/or intravenous cannulation
Who cannot join
- Participant with active SARS-CoV-2 infection, verified by RT-PCR test
- Participants tested positive for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus (HBsAg screen) or Hepatitis C virus (HCV antibody screen)
- 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
- History of any reaction to monoclonal antibodies
- History of clinically relevant atopic diseases and/or known allergies to the trial product or its components
- 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
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- Any clinically significant laboratory findings at screening and enrolment and at Day-1; one retest is allowed at screening and/or at Day-1
- Acute illness (moderate or severe) and/or fever (body temperature ≥ 38 °C) during the 72 hours prior to planned study drug application
- Participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder
- Receipt of immunoglobulin or blood products within 6 months prior to enrolment
- Receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer
- Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study
- Receipt of any standard vaccine within 14 days prior to Day 1
- History of alcoholism or drug addiction (as per DSM-V) within 1 year prior to screening
- 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
- 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
- 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)
- Pregnant, lactating, or planned pregnancy during the study period
- Inability to comply with the study protocol in the opinion of the investigator
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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, 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.
Read the detailed description
Despite the rapid rollout of vaccines against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), there is still a need for therapeutic and prophylactic treatments against the Coronavirus Disease 2019 (COVID-19) especially for those individuals who are not sufficiently protected by vaccines, i.e., a significant proportion of people of older age, the immunocompromised and those having various comorbidities.
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.
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, DLT-driven approach in healthy volunteers. Additional data to define the RP2D will also be determined.
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 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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- MTx-COVAB36, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTx-COVAB36Drug
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.
PlaceboDrug
0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| MTx-COVAB36 | Active comparator | 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. Receives: Drug: MTx-COVAB36 |
| Placebo | Placebo comparator | Placebo (0.9% NaCl) will be administered as a single dose intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To investigate the incidence, severity and causal relationship of AEs following single dose IV administration of MTx-COVAB36 to healthy volunteers.
Measured: Day 1 (IMP administration day) to Day 63 (Final visit)
Secondary outcomes (6)
Pharmacokinetics measured by the maximum plasma concentration (Cmax)
To describe the pharmacokinetics of MTx-COVAB36 in healthy volunteers after single dose intravenous administration.
Measured: Day 1 (IMP administration day) to Day 63 (Final visit)
Pharmacokinetics measured by the area under the concentration-time curve (AUC)
To describe the pharmacokinetics of MTx-COVAB36 in healthy volunteers after single dose intravenous administration.
Measured: Day 1 (IMP administration day) to Day 63 (Final visit)
Pharmacokinetics measured by the apparent clearance (CL)
To describe the pharmacokinetics of MTx-COVAB36 in healthy volunteers after single dose intravenous administration.
Measured: Day 1 (IMP administration day) to Day 63 (Final visit)
Pharmacokinetics measured by the terminal half-life (t1/2)
To describe the pharmacokinetics of MTx-COVAB36 in healthy volunteers after single dose intravenous administration.
Measured: Day 1 (IMP administration day) to Day 63 (Final visit)
Immunogenicity measured by anti-drug antibody (ADA) production
Assessment of the incidence and intensity of ADA production
Measured: Day 1 (IMP administration day), Day 8 and Day 29 post-administration and at Day 63 (final visit).
Immunogenicity measured by drug neutralizing antibody (Nab) production
Assessment of the incidence and intensity of Nab production.
Measured: Day 1 (IMP administration day), Day 8 and Day 29 post-administration and at Day 63 (final visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start26 Apr 2022
- Primary completion4 Sep 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, placebo-controlled study in healthy volunteers. 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 predefined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be randomized into study arms (MTx-COVAB36 or placebo).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memo Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351437
- Sponsor's protocol ID
- MTx-COVAB36-AU-1.02CoV
- Status last verified
- Nov 2022
- First submitted
- 28 Mar 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Sponsor, will not be sharing data with anyone outside of Vakzine Projekt Management (VPM GmbH) and the CRO (Accelagen) involved in the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05351437
- Acronym / sponsor ID
- MTx-COVAB36-AU-1.02CoV
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Memo Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Detailed description
Despite the rapid rollout of vaccines against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), there is still a need for therapeutic and prophylactic treatments against the Coronavirus Disease 2019 (COVID-19) especially for those individuals who are not sufficiently protected by vaccines, i.e., a significant proportion of people of older age, the immunocompromised and those having various comorbidities.
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.
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, DLT-driven approach in healthy volunteers. Additional data to define the RP2D will also be determined.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, placebo-controlled study in healthy volunteers. 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 predefined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be randomized into study arms (MTx-COVAB36 or placebo).
| Arm | Type | Receives |
|---|---|---|
| MTx-COVAB36 | Active comparator | Drug: MTx-COVAB36Cohort 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 | Placebo comparator | Drug: PlaceboPlacebo (0.9% NaCl) will be administered as a single dose intravenously. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female participants aged 18 years to 50 years at the time of consent
- Ability to read, understand and provide written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- 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
- Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive)
Key exclusion criteria (22 listed)
- Participant with active SARS-CoV-2 infection, verified by RT-PCR test
- Participants tested positive for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus (HBsAg screen) or Hepatitis C virus (HCV antibody screen)
- 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
- History of any reaction to monoclonal antibodies
- History of clinically relevant atopic diseases and/or known allergies to the trial product or its components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTx-COVAB36MTx-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. | Drug | MTx-COVAB36 |
| Placebo0.9% saline | Drug | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Day 1 (IMP administration day) to Day 63 (Final visit)
To investigate the incidence, severity and causal relationship of AEs following single dose IV administration of MTx-COVAB36 to healthy volunteers.
6 secondary outcomes
Pharmacokinetics measured by the maximum plasma concentration (Cmax)
Time frame: Day 1 (IMP administration day) to Day 63 (Final visit)
Pharmacokinetics measured by the area under the concentration-time curve (AUC)
Time frame: Day 1 (IMP administration day) to Day 63 (Final visit)
Pharmacokinetics measured by the apparent clearance (CL)
Time frame: Day 1 (IMP administration day) to Day 63 (Final visit)
Pharmacokinetics measured by the terminal half-life (t1/2)
Time frame: Day 1 (IMP administration day) to Day 63 (Final visit)
Immunogenicity measured by anti-drug antibody (ADA) production
Time frame: Day 1 (IMP administration day), Day 8 and Day 29 post-administration and at Day 63 (final visit).
Immunogenicity measured by drug neutralizing antibody (Nab) production
Time frame: Day 1 (IMP administration day), Day 8 and Day 29 post-administration and at Day 63 (final visit).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No. The Sponsor, will not be sharing data with anyone outside of Vakzine Projekt Management (VPM GmbH) and the CRO (Accelagen) involved in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTx-COVAB36 in people with SARS-CoV-2 Infection, run by Memo Therapeutics AG at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Day 1 (IMP administration day) to Day 63 (Final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.