What is SRK-439 studying in healthy adults?

SRK-439 is being studied to understand its safety, how it is processed by the body, and its biological effects in healthy adults. This phase 1 trial by Scholar Rock, Inc. aims to gather early information about the drug's behavior and tolerability in people without health conditions.

Who may be eligible for this healthy adult clinical trial?

Adults aged 18 to 55 years, both male and female, with a BMI between 18 and 35 kg/m2 may be eligible. Participants should be healthy and not have used certain muscle-related treatments recently. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy adult clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 18Years - 55Years

All Genders

Healthy Volunteers

ID07444294

A Phase 1 Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRK-439 in Healthy Adults

Led by Scholar Rock, Inc. · Updated on 2026-03-02

Participants Needed

Research Sites

24 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug SRK-439 in healthy adults aged 18 to 55 years. It is a phase 1 clinical trial designed to study how the drug behaves in the body and its safety profile in this population. The study is sponsored by Scholar Rock, Inc. and includes healthy volunteers to understand the drugs effects without underlying disease influence. Participants will receive either a single dose or multiple doses of SRK-439 administered subcutaneously, or matching placebo injections. The study is randomized and uses a quadruple masking approach, meaning participants, care providers, investigators, and outcomes assessors do not know who receives the drug or placebo. There are two parts Part A for single ascending doses and Part B for multiple ascending doses of SRK-439. During the study, participants will be monitored for up to 32 weeks to assess safety and tolerability, as well as to analyze pharmacokinetics and pharmacodynamics. Researchers will perform regular assessments including physical exams, laboratory tests, and monitoring for any side effects or immune responses. The study involves detailed observation to track how the drug is processed in the body and its biological effects over time.

CONDITIONS

Brief Title

A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults

Who Can Participate

Age: 18Years - 55Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Male or female participants aged 18 to 55 years at the time of informed consent
Body mass index (BMI) between 18 kg/m2 and 35 kg/m2 at screening

You will not qualify if you...

Previous treatment with SRK-439, apitegromab, or other anti-myostatin therapies, including ACTR antagonists
History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening
Current or prior use of anabolic steroids, growth hormones, or substances affecting muscle
Use of therapies with significant muscle effects within 3 months prior to screening or during the study
History of hypersensitivity reactions to monoclonal antibodies or Fc domain-bearing recombinant proteins within 5 years prior to screening
Treatment with other investigational drugs or biologic therapeutics within 3 months or 5 half-lives prior to screening

Research Team

Scholar Rock, Inc. Clinical Trials Administration

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