HealthyPhase 1NCT05505448
A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
A Phase 1 study testing REGN14284 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 REGN14284 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?
- REGN14284
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2022to 30 May 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 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/m2 (inclusive) at the screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety testing and ECGs performed at screening and/or prior to administration 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 a history of alcohol or drug abuse as determined by the investigator
- Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction to drugs or food as described in the protocol
- Use of any 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 as described in the protocol
- Participated in any clinical research study evaluating another investigational drug including biologics or 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
- NOTE: Other protocol defined inclusion / exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, B-3000
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Regeneron Anti-SARS-CoV-2 Monoclonal Antibody (a COVID-19 Therapeutic) in Adult Healthy Volunteers
The primary objective of the study is to evaluate the safety and tolerability of REGN14284 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 REGN14284 in serum
- To assess the immunogenicity of REGN14284
- Conditions
- Healthy
- Being tested
- REGN14284, Matching Placebo
- Keywords
- Coronavirus disease 2019 (COVID-19) vaccinated, Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN14284Drug
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 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
| Cohort 2 Mid SC Dose | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
| Cohort 3 High IV Dose | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
| Cohort 4 High SC Dose | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
| Cohort 5 Higher IV Dose | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
| Cohort 6 Highest IV Dose | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
| Cohort 7 Low IV Dose | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
| Cohort 8 Low SC Dose | Experimental | Randomized 3:1 for single ascending dose Receives: Drug: REGN14284; Drug: Matching Placebo |
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 approximately day 169
Occurrence and severity of all severe adverse events (SAEs)
Measured: Through approximately day 169
Secondary outcomes (3)
Concentrations of REGN14284 in serum over time
Measured: Through approximately day 169
Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time
Measured: Through approximately day 90
Titer of ADAs to REGN14284 over time
Measured: Through approximately day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start15 Sep 2022
- Primary completion30 May 2023
- Study completion30 May 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
- 48 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
- NCT05505448
- Sponsor's protocol ID
- R14284-HV-2253
- Other IDs
- 2022-002181-33
- Status last verified
- Jul 2023
- First submitted
- 15 Aug 2022
- Last updated
- 27 Jul 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 27 Jul 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 a Regeneron Anti-SARS-CoV-2 Monoclonal Antibody (a COVID-19 Therapeutic) in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05505448
- Acronym / sponsor ID
- R14284-HV-2253
- Conditions
- Healthy
- Keywords
- Coronavirus disease 2019 (COVID-19) vaccinated, Negative SARS-CoV-2 diagnostic test within approximately ≤72 hours of randomization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 17 Aug 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 REGN14284 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 REGN14284 in serum
- To assess the immunogenicity of REGN14284
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Mid IV Dose | Experimental | Drug: REGN14284, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Cohort 2 Mid SC Dose | Experimental | Drug: REGN14284, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Cohort 3 High IV Dose | Experimental | Drug: REGN14284, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Cohort 4 High SC Dose | Experimental | Drug: REGN14284, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Cohort 5 Higher IV Dose | Experimental | Drug: REGN14284, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Cohort 6 Highest IV Dose | Experimental | Drug: REGN14284, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Cohort 7 Low IV Dose | Experimental | Drug: REGN14284, Drug: Matching PlaceboRandomized 3:1 for single ascending dose |
| Cohort 8 Low SC Dose | Experimental | Drug: REGN14284, 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 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/m2 (inclusive) at the screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety testing and ECGs performed at screening and/or prior to administration of study drug
Key exclusion criteria (8 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 a history of alcohol or drug abuse as determined by the investigator
- Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction to drugs or food as described in the protocol
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 |
|---|---|---|
| REGN14284Single 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 Highest IV Dose, Cohort 7 Low IV Dose, Cohort 8 Low SC Dose |
| 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 Highest IV Dose, Cohort 7 Low IV Dose, Cohort 8 Low SC Dose |
Primary outcome
Occurrence and severity of all treatment emergent adverse events (TEAEs)
Time frame: Through approximately day 169
Occurrence and severity of all severe adverse events (SAEs)
Time frame: Through approximately day 169
3 secondary outcomes
Concentrations of REGN14284 in serum over time
Time frame: Through approximately day 169
Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time
Time frame: Through approximately day 90
Titer of ADAs to REGN14284 over time
Time frame: Through approximately day 90
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 Jul 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 REGN14284 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 4 inclusion and 8 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 Jul 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 approximately 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 27 Jul 2023.