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OpenTrials
Completed

NCT Number: NCT06137482

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research

Christchurch, Canterbury, 8011, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REGN13335

Drug

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

Matching Placebo

Drug

Administered IV or SC, sequential ascending single dose

Primary outcomes

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

    Time frame: Baseline to day 113

  2. Severity of TEAE's through the EOS visit

    Time frame: Baseline to day 113

Secondary outcomes

  1. Concentrations of functional REGN13335 in plasma through the EOS visit

    Time frame: Baseline to day 113

  2. Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time

    Time frame: Baseline to day 113

  3. Titer of ADA to single doses of REGN13335 over time

    Time frame: Baseline to day 113

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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