Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07444294
Eligibility Criteria:
Key Inclusion Criteria:
1. Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent
2. BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening
Exclusion Criteria:
1. Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR antagonists.
2. History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.
3. Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle.
4. 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.
5. 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
6. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07444294
Study Brief:
Protocol Section:
NCT07444294