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Recruiting NCT07444294

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, SRK-439, SRK-439.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Placebo
    Matching placebo to SRK-439, subcutaneous administration
  • Drug SRK-439
    Single ascending dose, subcutaneous administration
  • Drug SRK-439
    Multiple ascending dose, subcutaneous administration

Primary outcome measures

  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
Secondary outcome measures (6)
  • Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the PD of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]
  • Evaluate the immunogenicity of single and multiple SRK-439 SC dose administration in healthy adult participants [Time frame: Up to 32 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medpace CPU — Cincinnati

Identifiers

NCT: NCT07444294 · SRK-439-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗