HealthyPhase 1NCT05293678
Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19
A Phase 1 study testing REGN15160 (IV) and REGN15160 (SC) in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REGN15160 (IV) and REGN15160 (SC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Apr 2022to 26 Jan 2023
- 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 using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards
- 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/m2 (inclusive) at the screening visit
- Is judged by the investigator to be in good health based on medical history, as defined in the protocol
- Is in good health based on laboratory safety testing obtained at the screening visit
Who cannot join
- History of clinically significant disease and any concern, as defined in the protocol and as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
- 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
- Use of any prescription and non-prescription medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed
- Participated in any clinical research study evaluating another investigational drug including biologics or therapy, including specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit
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- Is a pregnant or breastfeeding woman
- Is a woman of childbearing potential (WOCBP)1 who is unwilling to practice highly effective contraception (as defined in the protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after study drug administration
- 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 Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers
The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).
The secondary objectives of the study are:
- To assess the concentration-time profile of REGN15160 in serum
- To assess the immunogenicity of REGN15160
- Conditions
- Healthy
- Being tested
- REGN15160 (IV), Matching Placebo (IV), REGN15160 (SC), Matching Placebo (SC)
- Keywords
- Vaccinated, Negative SARS-CoV2 Test Result
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN15160 (IV)Drug
Administered in single intravenous (IV) dose
Matching Placebo (IV)Drug
Administered in single IV dose
REGN15160 (SC)Drug
Administered in single subcutaneous (SC) dose
Matching Placebo (SC)Drug
Administered in single SC dose
| Study group | Role | What they receive |
|---|---|---|
| Lower IV Dose | Experimental | Randomized 3:1 Receives: Drug: REGN15160 (IV); Drug: Matching Placebo (IV) |
| Mid IV Dose 1 | Experimental | Randomized 3:1 Receives: Drug: REGN15160 (IV); Drug: Matching Placebo (IV) |
| Mid IV Dose 2 | Experimental | Randomized 3:1 Receives: Drug: REGN15160 (IV); Drug: Matching Placebo (IV) |
| Higher IV Dose | Experimental | Randomized 3:1 Receives: Drug: REGN15160 (IV); Drug: Matching Placebo (IV) |
| Lower SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN15160 (SC); Drug: Matching Placebo (SC) |
| Mid SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN15160 (SC); Drug: Matching Placebo (SC) |
| Higher SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN15160 (SC); Drug: Matching Placebo (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and severity of all treatment emergent adverse events (TEAEs)
Measured: Through Day 169
Occurrence and severity of all serious adverse events (SAEs)
Measured: Through Day 169
Secondary outcomes (2)
Concentrations of REGN15160 in serum
Measured: Through Day 169
Incidence and titer of anti-drug antibodies (ADA) to REGN15160
Measured: Through Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start12 Apr 2022
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 104 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
- NCT05293678
- Sponsor's protocol ID
- R15160-HV-2203
- Other IDs
- 2022-000182-41
- Status last verified
- Feb 2023
- First submitted
- 21 Mar 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. 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 Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05293678
- Acronym / sponsor ID
- R15160-HV-2203
- Conditions
- Healthy
- Keywords
- Vaccinated, Negative SARS-CoV2 Test Result
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 24 Mar 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.
The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).
The secondary objectives of the study are:
- To assess the concentration-time profile of REGN15160 in serum
- To assess the immunogenicity of REGN15160
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Lower IV Dose | Experimental | Drug: REGN15160 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Mid IV Dose 1 | Experimental | Drug: REGN15160 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Mid IV Dose 2 | Experimental | Drug: REGN15160 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Higher IV Dose | Experimental | Drug: REGN15160 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Lower SC Dose | Experimental | Drug: REGN15160 (SC), Drug: Matching Placebo (SC)Randomized 3:1 |
| Mid SC Dose | Experimental | Drug: REGN15160 (SC), Drug: Matching Placebo (SC)Randomized 3:1 |
| Higher SC Dose | Experimental | Drug: REGN15160 (SC), Drug: Matching Placebo (SC)Randomized 3:1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards
- 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/m2 (inclusive) at the screening visit
- Is judged by the investigator to be in good health based on medical history, as defined in the protocol
- Is in good health based on laboratory safety testing obtained at the screening visit
Key exclusion criteria (9 listed)
- History of clinically significant disease and any concern, as defined in the protocol and as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
- 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
- Use of any prescription and non-prescription medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed
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 |
|---|---|---|
| REGN15160 (IV)Administered in single intravenous (IV) dose | Drug | Higher IV Dose, Lower IV Dose, Mid IV Dose 1, Mid IV Dose 2 |
| Matching Placebo (IV)Administered in single IV dose | Drug | Higher IV Dose, Lower IV Dose, Mid IV Dose 1, Mid IV Dose 2 |
| REGN15160 (SC)Administered in single subcutaneous (SC) dose | Drug | Higher SC Dose, Lower SC Dose, Mid SC Dose |
| Matching Placebo (SC)Administered in single SC dose | Drug | Higher SC Dose, Lower SC Dose, Mid SC Dose |
Primary outcome
Occurrence and severity of all treatment emergent adverse events (TEAEs)
Time frame: Through Day 169
Occurrence and severity of all serious adverse events (SAEs)
Time frame: Through Day 169
2 secondary outcomes
Concentrations of REGN15160 in serum
Time frame: Through Day 169
Incidence and titer of anti-drug antibodies (ADA) to REGN15160
Time frame: Through Day 169
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 23 Feb 2023.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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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.
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 REGN15160 (IV) and REGN15160 (SC) in people with Healthy, 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 5 inclusion and 9 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 23 Feb 2023. 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 and severity of all treatment emergent adverse events (TEAEs) (time frame: Through Day 169). The study lists 2 primary outcomes in all. 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 23 Feb 2023.