A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are 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 Volunteer

Treatments: Drug: Matching Placebo (IV); Drug: REGN7508 (IV); Drug: Matching Placebo (SC); Drug: REGN7508 (SC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05603195

R7508-HV-21102

2022-002001-20 (EudraCT Number)

Details and patient eligibility

About

This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.

This study is looking at several other research questions, including:

• What side effects may happen from taking the study drug
• How much study drug is in the blood at different times
• Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
2. Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and echocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug
3. Participant is in good health based on laboratory safety testing obtained at the screening visit and/or prior to administration of initial dose of study drug
4. Normal activated partial thromboplastin time (aPTT), normal prothrombin time (PT), and normal platelet counts at screening period and at the day -1 visit as defined by the local laboratory
5. Hemoglobin value ≥11.0 g/dL for females and ≥12.9 g/dL for males at the screening and day 1 visits

Key Exclusion Criteria:

1. History of any major surgical procedure or clinically significant physical trauma, in the opinion of the investigator, that may pose a risk to the participant by study participation
2. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit
3. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation, as defined in the protocol
4. Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 at screening
5. Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
6. Confirmed positive drug test result at the screening visit and/or prior to randomization or a history of drug abuse within a year prior to the screening visit
7. History of alcohol abuse within the last 2 years prior to the day 1 visit
8. Any malignancy, except for nonmelanoma skin cancer or cervical/anus in situ, that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
9. History of significant multiple and/or severe allergies (eg, latex gloves) or has had an anaphylactic reaction to prescription or nonprescription drugs or food

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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80 participants in 10 patient groups

Cohort 1 Lowest IV Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: REGN7508 (IV)

Drug: Matching Placebo (IV)

Cohort 2 Low IV Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: REGN7508 (IV)

Drug: Matching Placebo (IV)

Cohort 3 Mid IV Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: REGN7508 (IV)

Drug: Matching Placebo (IV)

Cohort 4 High IV Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: REGN7508 (IV)

Drug: Matching Placebo (IV)

Cohort 5 Higher IV Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: REGN7508 (IV)

Drug: Matching Placebo (IV)

Cohort 6 High SC Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: Matching Placebo (SC)

Drug: REGN7508 (SC)

Cohort 7 Higher SC Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: Matching Placebo (SC)

Drug: REGN7508 (SC)

Optional: Cohort 8 Highest IV or SC Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: Matching Placebo (SC)

Drug: REGN7508 (SC)

Drug: REGN7508 (IV)

Drug: Matching Placebo (IV)

Cohort 9 High SC Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: Matching Placebo (SC)

Drug: REGN7508 (SC)

Optional: Cohort 10 Highest SC Dose

Experimental group

Description:

Randomized 3:1

Treatment:

Drug: Matching Placebo (SC)

Drug: REGN7508 (SC)