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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06137482

Collaborator

(none)

Enrollment

Arms

9.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: REGN13335 Drug: Matching Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN13335, a Platelet-Derived Growth Factor-B Antagonist, in Healthy Adult Participants

Anticipated Study Start Date :

Dec 5, 2023

Anticipated Primary Completion Date :

Sep 11, 2024

Anticipated Study Completion Date :

Sep 11, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IV Cohort 1 Low Dose Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose
Experimental: IV Cohort 2 Mid Dose Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose
Experimental: IV Cohort 3 High Dose Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose
Experimental: IV Cohort 4 Higher Dose Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose
Experimental: SC Cohort 1 Low Dose Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose
Experimental: SC Cohort 2 High Dose Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose
Experimental: IV or SC Optional Cohort 1 Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose
Experimental: IV or SC Optional Cohort 2 Randomized (6:2) to REGN13335 or placebo	Drug: REGN13335 Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose Drug: Matching Placebo Administered IV or SC, sequential ascending single dose

Outcome Measures

Primary Outcome Measures

Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) [Baseline to day 113]
Severity of TEAE's through the EOS [Baseline to day 113]

Secondary Outcome Measures

Concentrations of functional REGN13335 in plasma through the EOS visit [Baseline to day 113]
Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time [Baseline to day 113]
Titer of ADA to single doses of REGN13335 over time [Baseline to day 113]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

Has a body mass index between 18 and 32 kg/m^2, 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 tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)

Key Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT06137482

Other Study ID Numbers:

R13335-HV-2289

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Nov 18, 2023