Healthy VolunteersPhase 1NCT05923424
A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults
A Phase 1 study testing REGN17092 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN17092
- 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 siteBelgium
- Study dates
- 28 Nov 2023to 4 Mar 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol
- Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
- Has a body mass index (BMI) between 18 and 31 Kg/m^2 (inclusive) at the screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose of study drug
Who cannot join
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol
- Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
- Has history of alcohol or drug abuse as determined by the investigator
- Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
- 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, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers
The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people.
Other aims are to assess:
- How much of the study drug is in the blood at different times
- Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)
- Conditions
- Healthy Volunteers
- Being tested
- REGN17092, Matching Placebo
- Keywords
- Severe acute respiratory syndrome coronavirus (SARS-CoV-19), Coronavirus disease 2019 (COVID-19) vaccinated, Omicron variant
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN17092Drug
Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Matching PlaceboDrug
Single ascending IV or SC administration per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Mid IV Dose | Experimental | Randomized 6:2 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Cohort 3 High IV Dose | Experimental | Randomized 6:2 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Cohort 5 Higher IV Dose | Experimental | Randomized 6:2 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Cohort 6 Low IV Dose | Experimental | Randomized 6:2 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Cohort 2 Mid SC Dose | Experimental | Randomized 6:2 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Cohort 4 High SC Dose | Experimental | Randomized 6:2 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Cohort 7 Low SC Dose | Experimental | Randomized 6:2 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Expansion Cohort 1 | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Expansion Cohort 2 | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
| Expansion Cohort 3 | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN17092; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of all treatment emergent adverse events (TEAEs)
Measured: Through approximately day 365
Severity of all TEAEs
Measured: Through approximately day 365
Occurrence of all treatment emergent serious adverse events (TE-SAEs)
Measured: Through approximately day 365
Severity of all TE-SAEs
Measured: Through approximately day 365
Secondary outcomes (3)
Concentrations of REGN17092 in serum over time
Measured: Through approximately day 365
Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time
Measured: Through approximately day 365
Titer of ADAs to REGN17092 over time
Measured: Through approximately day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start28 Nov 2023
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923424
- Sponsor's protocol ID
- R17092-HV-2312
- Other IDs
- 2023- 505041-52-00, 2023
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Publications
Rosario M, de Hoon J, Isa F, Turner K, Li J, Kantrowitz J, Ganguly S, Fraser S, He ZW, Yan H, Ortiz AG, Faria L, Heirman I, Baum A, Norton TD, Patel Y, Casullo VM, Davis JD. Pharmacokinetics, Immunogenicity, and Safety of a Modified YTE Antibody in Healthy Adults. Clin Pharmacol Drug Dev. 2026 Oct;15(10):e70107. doi: 10.1002/cpdd.70107.
PubMed 42811441
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. 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 Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05923424
- Acronym / sponsor ID
- R17092-HV-2312
- Conditions
- Healthy Volunteers
- Keywords
- Severe acute respiratory syndrome coronavirus (SARS-CoV-19), Coronavirus disease 2019 (COVID-19) vaccinated, Omicron variant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 28 Jun 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.
The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people.
Other aims are to assess:
- How much of the study drug is in the blood at different times
- Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Mid IV Dose | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 6:2 for single ascending dose |
| Cohort 3 High IV Dose | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 6:2 for single ascending dose |
| Cohort 5 Higher IV Dose | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 6:2 for single ascending dose |
| Cohort 6 Low IV Dose | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 6:2 for single ascending dose |
| Cohort 2 Mid SC Dose | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 6:2 for single ascending dose |
| Cohort 4 High SC Dose | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 6:2 for single ascending dose |
| Cohort 7 Low SC Dose | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 6:2 for single ascending dose |
| Expansion Cohort 1 | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Expansion Cohort 2 | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Expansion Cohort 3 | Experimental | Drug: REGN17092, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol
- Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
- Has a body mass index (BMI) between 18 and 31 Kg/m^2 (inclusive) at the screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose of study drug
Key exclusion criteria (6 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol
- Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
- Has history of alcohol or drug abuse as determined by the investigator
- Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
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 |
|---|---|---|
| REGN17092Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol | Drug | Cohort 1 Mid IV Dose, Cohort 2 Mid SC Dose, Cohort 3 High IV Dose, Cohort 4 High SC Dose, Cohort 5 Higher IV Dose, Cohort 6 Low IV Dose, Cohort 7 Low SC Dose, Expansion Cohort 1, Expansion Cohort 2, Expansion Cohort 3 |
| Matching PlaceboSingle ascending IV or SC administration per the protocol | Drug | Cohort 1 Mid IV Dose, Cohort 2 Mid SC Dose, Cohort 3 High IV Dose, Cohort 4 High SC Dose, Cohort 5 Higher IV Dose, Cohort 6 Low IV Dose, Cohort 7 Low SC Dose, Expansion Cohort 1, Expansion Cohort 2, Expansion Cohort 3 |
Primary outcome
Occurrence of all treatment emergent adverse events (TEAEs)
Time frame: Through approximately day 365
Severity of all TEAEs
Time frame: Through approximately day 365
Occurrence of all treatment emergent serious adverse events (TE-SAEs)
Time frame: Through approximately day 365
Severity of all TE-SAEs
Time frame: Through approximately day 365
3 secondary outcomes
Concentrations of REGN17092 in serum over time
Time frame: Through approximately day 365
Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time
Time frame: Through approximately day 365
Titer of ADAs to REGN17092 over time
Time frame: Through approximately day 365
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 27 Mar 2025.
- Derived from this study: PubMed 42811441Rosario M, de Hoon J, Isa F, Turner K, Li J, Kantrowitz J, Ganguly S, Fraser S, He ZW, Yan H, Ortiz AG, Faria L, Heirman I, Baum A, Norton TD, Patel Y, Casullo VM, Davis JD. Pharmacokinetics, Immunogenicity, and Safety of a Modified YTE Antibody in Healthy Adults. Clin Pharmacol Drug Dev. 2026 Oct;15(10):e70107. doi: 10.1002/cpdd.70107.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Screening Protocol
Pain
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 REGN17092 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in Belgium.
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 4 inclusion and 6 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 27 Mar 2025. 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 Belgium. 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?
Occurrence of all treatment emergent adverse events (TEAEs) (time frame: Through approximately day 365). The study lists 4 primary outcomes in all. 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 NCT05923424, 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 27 Mar 2025.