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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: REGN13335; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Recruiting
      • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Estimated): September 12, 2024
• Study Completion (Estimated): September 12, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: R13335-HV-2289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
• IPD Sharing Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes