COVID-19Phase 1NCT06523153
A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants
A Phase 1 study testing VYD2311 in people with COVID-19, run by Invivyd, Inc. at 1 site in Australia.
Trial summary
A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- VYD2311
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Aug 2024to May 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a male or female participant aged 18 to 65 years, inclusive.
- Has a body mass index 18.0 to 32.0 kg/m2, inclusive.
- Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, ECG, and laboratory values per study unit standard operating procedures.
- Tests negative for current SARS-CoV-2 infection by rapid antigen test on screening and Day -1.
- For participants assigned female sex at birth:
- Is not of childbearing potential (defined in protocol), OR
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- Is of childbearing potential (defined in protocol) and practicing highly effective contraception (defined in protocol) for at least 28 days before dosing (Day 1) through 6 months after dosing and has negative results on pregnancy tests at Screening and on Day -1.
- Is able and willing to provide written informed consent.
- Is able to understand the study procedures and willing to adhere to all protocol requirements.
Who cannot join
- Has a known or suspected allergy, intolerance, or hypersensitivity to any component of the study drug, including excipients and closely related compounds (eg, other mAbs).
- Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1.
- Is pregnant, breastfeeding, or seeking pregnancy while on study.
- Has any chronic or significant medical condition that, in the assessment of the Investigator, might compromise participant safety or interfere with evaluation of the study drug or interpretation of participant safety/study results, including but not limited to significant neurologic, renal, hepatic, hematologic, immune, cardiac, pulmonary, metabolic, endocrine, psychiatric, vascular, or gastrointestinal disorders.
- Has a history of a malignancy (or active malignancy), except for participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix who have been treated and cured.
- Has had any symptoms of acute respiratory illness (eg, cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing.
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- Has evidence of active infection with HIV, HBV, or HCV, as indicated by any of the following: positive antibody, antigen, or nucleic acid amplification test result for HIV; positive HBV surface antigen; positive HCV antibody with positive HCV RNA (positive antibody test with negative RNA test is not exclusionary).
- Has current alcoholism or recreational drug use, including a positive test result for marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines, or alcohol.
- Is a current or former regular cigarette smoker (more than 5 cigarettes per day within the last year). Individuals who currently or previously smoked 5 or fewer cigarettes per day are allowed if they agree to abstain from smoking during confinement at the CRU.
- Has donated more than 500 mL of blood within 60 days before the scheduled dose of study drug.
- Had major surgery within 30 days prior to study drug dosing or has planned surgeries within 12 months after planned study drug dosing.
- Received any investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to Screening or planned administration of any investigational drug or biologic during the study period.
- Received immunoglobulin or blood products within 6 months prior to Screening
- Previously received a mAb within 6 months or 5 half-lives (whichever is longer) prior to Screening or previously received pemivibart (VYD222) at any time.
- Has taken prescription or OTC medications or supplements within 5 half-lives of the specific substance (or, if half-life is not known, within 48 hours) before the scheduled administration of study drug, with the following exceptions:
- Influenza or COVID-19 vaccination more than 14 days prior to dosing, or any other vaccine more than 4 weeks prior to dosing
- Hormonal contraceptives
- Standard of care use of acetaminophen/paracetamol
- Vitamins and other nutritional supplements that are not newly introduced (ie, have been taken for at least 30 days prior to enrollment)
- Other OTC medications that, in the judgement of the Investigator or medically qualified designee, will not impact the safety of the participant or data integrity of the study.
- Screening or predose systolic blood pressure that repeatedly measures below approximately 100 mm Hg. If systolic blood pressure measures below 100 mm Hg, the measurement may be repeated twice. If the average of all three measurements is greater than or equal to 100 mm Hg, the participant may be considered eligible as determined by the Investigator or medically qualified designee.
- In the opinion of the Investigator, is unable to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a SARS-CoV-2-directed Monoclonal Antibody in Healthy Participants
A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants
Read the detailed description
This is a Phase I, first-in-human, randomized, double blind, placebo controlled, single escalating dose study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of VYD2311, a monoclonal antibody targeting SARS-CoV-2, in healthy volunteers.
The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD2311 after a single IV, IM, or SC administration in healthy participants. The secondary objectives are to evaluate the PK of VYD2311 after IV or IM administration and the immunogenicity of VYD2311 after IV, IM, or SC administration in healthy participants.
- Conditions
- COVID-19
- Being tested
- VYD2311, 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.
VYD2311Biological
Monoclonal antibody
PlaceboOther
Also called 0.9% sodium chloride
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| VYD2311 | Experimental | Injection in healthy volunteer Receives: Biological: VYD2311 |
| Placebo | Placebo comparator | Injection in healthy volunteer Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs (including AEs and SAEs)
Measured: Through Month-6 visit
Secondary outcomes (10)
PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity)
Measured: Through Month-6 visit
PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration)
Measured: Through Month-6 visit
PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t)
Measured: Through Month-6 visit
PK parameter of VYD2311, Cmax (maximum serum concentration)
Measured: Through Month-6 visit
PK parameter of VYD2311, Tmax (time to reach maximum serum concentration)
Measured: Through Month-6 visit
PK parameter of VYD2311, CL (clearance)
Measured: Through Month-6 visit
PK parameter of VYD2311, t1/2 (half-life)
Measured: Through Month-6 visit
PK parameter of VYD2311, Vss (apparent volume of distribution at steady state)
Measured: Through Month-6 visit
PK parameter of VYD2311, Vz (apparent volume of distribution during terminal phase)
Measured: Through Month-6 visit
Incidence of ADAs against VYD2311
Measured: Through Month-6 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start28 Aug 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, double blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invivyd, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523153
- Sponsor's protocol ID
- VYD2311-1-001
- Status last verified
- Nov 2024
- First submitted
- 18 Jul 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a SARS-CoV-2-directed Monoclonal Antibody in Healthy Participants
- ClinicalTrials.gov ID
- NCT06523153
- Acronym / sponsor ID
- VYD2311-1-001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Invivyd, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 26 Jul 2024 (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.
A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants
Detailed description
This is a Phase I, first-in-human, randomized, double blind, placebo controlled, single escalating dose study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of VYD2311, a monoclonal antibody targeting SARS-CoV-2, in healthy volunteers.
The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD2311 after a single IV, IM, or SC administration in healthy participants. The secondary objectives are to evaluate the PK of VYD2311 after IV or IM administration and the immunogenicity of VYD2311 after IV, IM, or SC administration in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| VYD2311 | Experimental | Biological: VYD2311Injection in healthy volunteer |
| Placebo | Placebo comparator | Other: PlaceboInjection in healthy volunteer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is a male or female participant aged 18 to 65 years, inclusive.
- Has a body mass index 18.0 to 32.0 kg/m2, inclusive.
- Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, ECG, and laboratory values per study unit standard operating procedures.
- Tests negative for current SARS-CoV-2 infection by rapid antigen test on screening and Day -1.
- For participants assigned female sex at birth:
Key exclusion criteria (22 listed)
- Has a known or suspected allergy, intolerance, or hypersensitivity to any component of the study drug, including excipients and closely related compounds (eg, other mAbs).
- Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1.
- Is pregnant, breastfeeding, or seeking pregnancy while on study.
- Has any chronic or significant medical condition that, in the assessment of the Investigator, might compromise participant safety or interfere with evaluation of the study drug or interpretation of participant safety/study results, including but not limited to significant neurologic, renal, hepatic, hematologic, immune, cardiac, pulmonary, metabolic, endocrine, psychiatric, vascular, or gastrointestinal disorders.
- Has a history of a malignancy (or active malignancy), except for participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix who have been treated and cured.
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 |
|---|---|---|
| VYD2311Monoclonal antibody | Biological | VYD2311 |
| PlaceboAlso: 0.9% sodium chlorideMatching Placebo | Other | Placebo |
Primary outcome
Incidence of TEAEs (including AEs and SAEs)
Time frame: Through Month-6 visit
10 secondary outcomes
PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity)
Time frame: Through Month-6 visit
PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration)
Time frame: Through Month-6 visit
PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t)
Time frame: Through Month-6 visit
PK parameter of VYD2311, Cmax (maximum serum concentration)
Time frame: Through Month-6 visit
PK parameter of VYD2311, Tmax (time to reach maximum serum concentration)
Time frame: Through Month-6 visit
PK parameter of VYD2311, CL (clearance)
Time frame: Through Month-6 visit
PK parameter of VYD2311, t1/2 (half-life)
Time frame: Through Month-6 visit
PK parameter of VYD2311, Vss (apparent volume of distribution at steady state)
Time frame: Through Month-6 visit
PK parameter of VYD2311, Vz (apparent volume of distribution during terminal phase)
Time frame: Through Month-6 visit
Incidence of ADAs against VYD2311
Time frame: Through Month-6 visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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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 VYD2311 in people with COVID-19, run by Invivyd, Inc. 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 9 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of TEAEs (including AEs and SAEs) (time frame: Through Month-6 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 19 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.