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

NCT07444294 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SRK-439-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  • Incidence of AEs

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  • Incidence of SAEs

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in clinical safety laboratory tests (serum chemistry)

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in clinical safety laboratory tests (hematology)

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in clinical safety laboratory tests (urinalysis)

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in clinical safety laboratory tests (coagulation assessments)

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in vital signs (heart rate) measured in bpm

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in vital signs (blood pressure) measured in mmHg

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in vital signs (respiratory rate) measured in rpm

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in vital signs (body temperature) measured in Celsius

  Up to 32 weeks

• Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants

  Changes from baseline in ECG measurements

  Up to 32 weeks

Secondary Outcomes (6)

• Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants

  Up to 32 weeks

• Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants

  Up to 32 weeks

• Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants

  Up to 32 weeks

• Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants

  Up to 32 weeks

• Evaluate the PD of single and multiple SRK-439 SC dose administration in healthy adult participants

  Up to 32 weeks

Study Arms (2)

Part A

EXPERIMENTAL

Participants will be treated with a single dose of SRK-439 or matching placebo.

Drug: Placebo; Drug: SRK-439

Part B

EXPERIMENTAL

Participants will be treated with multiple doses of SRK-439 or matching placebo.

Drug: Placebo; Drug: SRK-439

Interventions

Placebo DRUG

Matching placebo to SRK-439, subcutaneous administration

Part A; Part B

SRK-439 DRUG

Single ascending dose, subcutaneous administration

Part A

Eligibility Criteria

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

You may qualify if:

• Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent
• BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening

You may not qualify if:

• Previous treatment with SRK-439 or apitegromab, or with 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 other substances with known effects on muscle.
• Use of therapies with potentially significant muscle effects (eg, insulin-like growth factor, systemic beta-agonist, neurotoxins, or muscle relaxants or muscle-enhancing supplements) in any form within 3 months prior to screening or during the study.
• Any history of exposure to a mAb or Fc domain-bearing recombinant protein within 5 years prior to screening with any prior history of hypersensitivity reactions from exposure
• Treatment with other investigational drugs or devices in a clinical study or exposure to a biologic therapeutic within 3 months or 5 half-lives, whichever is longer, prior to screening.

Sponsors & Collaborators

• Scholar Rock, Inc.: lead

Study Sites (1)

Medpace CPU

Cincinnati, Ohio, 45227, United States

RECRUITING

Central Study Contacts

Scholar Rock, Inc. Clinical Trials Administration

CONTACT

857-259-3860; MedicalInformation@scholarrock.com

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: February 11, 2026
• First Posted: March 2, 2026
• Study Start: November 21, 2025
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): June 9, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)