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

NCT ID: NCT05505448

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-05-30

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1 Mid IV Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Cohort 2 Mid SC Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Cohort 3 High IV Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Cohort 4 High SC Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Cohort 5 Higher IV Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Cohort 6 Highest IV Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Cohort 7 Low IV Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Cohort 8 Low SC Dose

Randomized 3:1 for single ascending dose

Group Type: EXPERIMENTAL

REGN14284

Intervention Type: DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type: DRUG

Single ascending IV or SC administration per the protocol

Interventions

REGN14284

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Intervention Type: DRUG

Matching Placebo

Single ascending IV or SC administration per the protocol

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, , Belgium

Countries

Belgium

Other Identifiers

2022-002181-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R14284-HV-2253

Identifier Type: -

Identifier Source: org_study_id