A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: REGN13335; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06137482

R13335-HV-2289

Details and patient eligibility

About

This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.

The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.

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

• What side effects may happen from taking the study drug
• How much study drug is present in the blood of study participants 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: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

56 participants in 8 patient groups

IV Cohort 1 Low Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335

IV Cohort 2 Mid Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335

IV Cohort 3 High Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335

IV Cohort 4 Higher Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335

IV Cohort 5 Highest Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335

SC Cohort 1 Low Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335

SC Cohort 2 High Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335

IV or SC Optional Cohort

Experimental group

Description:

≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol

Treatment:

Drug: Matching Placebo

Drug: REGN13335