A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks • Incidence of AEs
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks • Incidence of SAEs
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in clinical safety laboratory tests (serum chemistry)
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in clinical safety laboratory tests (hematology)
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in clinical safety laboratory tests (urinalysis)
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in clinical safety laboratory tests (coagulation assessments)
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in vital signs (heart rate) measured in bpm
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in vital signs (blood pressure) measured in mmHg
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in vital signs (respiratory rate) measured in rpm
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in vital signs (body temperature) measured in Celsius
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants — Up to 32 weeks Changes from baseline in ECG measurements
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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