COVID-19Phase 1NCT05791318
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants
A Phase 1 study testing VYD222 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 the monoclonal antibody VYD222 in healthy adult 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?
- VYD222
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Mar 2023to 8 May 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a body mass index 18.5 to 32.0 kg/m2, inclusive.
- Negative for current SARS-CoV-2 infection by rapid antigen test on Day -1.
- Is seropositive to N and/or S SARS-CoV-2 antigens at Screening.
- For participants assigned female sex at birth: Is not of childbearing potential OR is of childbearing potential and practicing highly effective contraception.
- Is able and willing to provide written informed consent.
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Who cannot join
- Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1.
- Is pregnant, breastfeeding, or seeking pregnancy while on study.
- 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 (e.g., cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing.
- Has evidence of active infection with HIV, HBV, or HCV.
- Has donated more than 500 mL of blood within 60 days before the scheduled dose of study drug.
Show all 11Show fewer
- Had major surgery within 30 days prior to study drug dosing or 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.
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Triple-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Monoclonal Antibody VYD222 in Healthy Adult Participants
A study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody VYD222 in healthy adult participants.
Read the detailed description
This is a Phase I, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of VYD222, a monoclonal antibody targeting SARS-CoV-2, in healthy adult volunteers.
The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD222 after a single administration in healthy participants. The secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of VYD222 after administration in healthy participants.
- Conditions
- COVID-19
- Being tested
- VYD222, 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.
VYD222Drug
Monoclonal antibody
PlaceboOther
Also called 0.9% sodium chloride
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo Receives: Drug: VYD222; Other: Placebo |
| Cohort 2 | Experimental | 10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo Receives: Drug: VYD222; Other: Placebo |
| Cohort 3 | Experimental | 10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo Receives: Drug: VYD222; 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 12 Months
Secondary outcomes (10)
Incidence of ADAs against VYD222
Measured: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222
Measured: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222
Measured: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222
Measured: 12 Months
Assessment of PK Parameter: Cmax (maximum serum concentration)
Measured: 12 Months
Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)
Measured: 12 Months
Assessment of PK Parameter: Clearance of VYD222
Measured: 12 Months
Assessment of PK Parameter: Half-life of VYD222
Measured: 12 Months
Assessment of PK Parameter: volume of distribution at steady state of VYD222
Measured: 12 Months
Assessment of PK Parameter: volume of distribution during terminal phase of VYD222
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start28 Mar 2023
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, triple blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- NCT05791318
- Sponsor's protocol ID
- VYD222-1-001
- Status last verified
- May 2024
- First submitted
- 16 Mar 2023
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Narayan K, Tosh K, Holmes A, Hu L, Dkottam SR, Yalcin I, Wingertzahn M. Serum Virus-Neutralizing Antibody Titers in Clinical Trial Participants With and Without Immunocompromise Receiving Pemivibart, a Long-Acting Monoclonal Antibody for COVID-19. J Infect Dis. 2026 Oct 15;234(4):e859-e868. doi: 10.1093/infdis/jiag269.
PubMed 42165235
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Triple-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Monoclonal Antibody VYD222 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05791318
- Acronym / sponsor ID
- VYD222-1-001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Invivyd, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 30 Mar 2023 (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 the monoclonal antibody VYD222 in healthy adult participants.
Detailed description
This is a Phase I, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of VYD222, a monoclonal antibody targeting SARS-CoV-2, in healthy adult volunteers.
The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD222 after a single administration in healthy participants. The secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of VYD222 after 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
- 3
- Model description
- Randomized, triple blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: VYD222, Other: Placebo10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo |
| Cohort 2 | Experimental | Drug: VYD222, Other: Placebo10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo |
| Cohort 3 | Experimental | Drug: VYD222, Other: Placebo10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a body mass index 18.5 to 32.0 kg/m2, inclusive.
- Negative for current SARS-CoV-2 infection by rapid antigen test on Day -1.
- Is seropositive to N and/or S SARS-CoV-2 antigens at Screening.
- For participants assigned female sex at birth: Is not of childbearing potential OR is of childbearing potential and practicing highly effective contraception.
- Is able and willing to provide written informed consent.
Key exclusion criteria (11 listed)
- Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1.
- Is pregnant, breastfeeding, or seeking pregnancy while on study.
- 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 (e.g., cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing.
- Has evidence of active infection with HIV, HBV, or HCV.
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 |
|---|---|---|
| VYD222Monoclonal antibody | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboAlso: 0.9% sodium chlorideMatching Placebo | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Incidence of TEAEs (including AEs and SAEs)
Time frame: Through 12 Months
10 secondary outcomes
Incidence of ADAs against VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222
Time frame: 12 Months
Assessment of PK Parameter: Cmax (maximum serum concentration)
Time frame: 12 Months
Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)
Time frame: 12 Months
Assessment of PK Parameter: Clearance of VYD222
Time frame: 12 Months
Assessment of PK Parameter: Half-life of VYD222
Time frame: 12 Months
Assessment of PK Parameter: volume of distribution at steady state of VYD222
Time frame: 12 Months
Assessment of PK Parameter: volume of distribution during terminal phase of VYD222
Time frame: 12 Months
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 31 May 2024.
- Derived from this study: PubMed 42165235Narayan K, Tosh K, Holmes A, Hu L, Dkottam SR, Yalcin I, Wingertzahn M. Serum Virus-Neutralizing Antibody Titers in Clinical Trial Participants With and Without Immunocompromise Receiving Pemivibart, a Long-Acting Monoclonal Antibody for COVID-19. J Infect Dis. 2026 Oct 15;234(4):e859-e868. doi: 10.1093/infdis/jiag269.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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 VYD222 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 6 inclusion and 11 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 31 May 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. 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?
Incidence of TEAEs (including AEs and SAEs) (time frame: Through 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791318, which also lists 1 linked publication.
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 31 May 2024.