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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: REGN14284; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05505448

2022-002181-33 (EudraCT Number)

R14284-HV-2253

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Has SARS-CoV-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol.
2. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
3. Has a body mass index (BMI) between 18 and 31 kg/m2 (inclusive) at the screening visit
4. 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:

1. 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
2. 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
3. Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
4. Has a history of alcohol or drug abuse as determined by the investigator
5. 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
6. 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
7. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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48 participants in 8 patient groups

Cohort 1 Mid IV Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284

Cohort 2 Mid SC Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284

Cohort 3 High IV Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284

Cohort 4 High SC Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284

Cohort 5 Higher IV Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284

Cohort 6 Highest IV Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284

Cohort 7 Low IV Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284

Cohort 8 Low SC Dose

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN14284