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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06137482

Enrollment

Registered

2023-11-18

Start date

2023-12-06

Completion date

2025-02-11

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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)

Interventions

DRUGREGN13335

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

DRUGMatching Placebo

Administered IV or SC, sequential ascending single dose

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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 /

Design outcomes

Primary

Measure	Time frame
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

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

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026