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

NCT06137482 | Completed Phase 1 FDA Drug

• 1 other identifier: R13335-HV-2289
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit

  Baseline to day 113

• Severity of TEAE's through the EOS visit

  Baseline to day 113

Secondary Outcomes (3)

• 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

Study Arms (8)

IV Cohort 1 Low Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN13335; Drug: Matching Placebo

IV Cohort 2 Mid Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN13335; Drug: Matching Placebo

IV Cohort 3 High Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN13335; Drug: Matching Placebo

IV Cohort 4 Higher Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN13335; Drug: Matching Placebo

IV Cohort 5 Highest Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN13335; Drug: Matching Placebo

SC Cohort 1 Low Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN13335; Drug: Matching Placebo

SC Cohort 2 High Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN13335; Drug: Matching Placebo

IV or SC Optional Cohort

EXPERIMENTAL

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

Drug: REGN13335; Drug: Matching Placebo

Interventions

REGN13335 DRUG

Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose

IV Cohort 1 Low Dose; IV Cohort 2 Mid Dose; IV Cohort 3 High Dose; IV Cohort 4 Higher Dose; IV Cohort 5 Highest Dose; IV or SC Optional Cohort; SC Cohort 1 Low Dose; SC Cohort 2 High Dose

Matching Placebo DRUG

Administered IV or SC, sequential ascending single dose

IV Cohort 1 Low Dose; IV Cohort 2 Mid Dose; IV Cohort 3 High Dose; IV Cohort 4 Higher Dose; IV Cohort 5 Highest Dose; IV or SC Optional Cohort; SC Cohort 1 Low Dose; SC Cohort 2 High Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

New Zealand Clinical Research

Christchurch, Canterbury, 8011, New Zealand

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 6, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
• 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

Locations

NZ (1)