Healthy
Conditions
Brief summary
A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults
Interventions
DRUGPlacebo
Matching placebo to SRK-439, subcutaneous administration
DRUGSRK-439
Single ascending dose, subcutaneous administration
Sponsors
Scholar Rock, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the PD of single and multiple SRK-439 SC dose administration in healthy adult participants | Up to 32 weeks | Serum concentrations of total latent myostatin and changes over time |
| Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants | Up to 32 weeks | • Maximum observed serum concentration \[Cmax\] |
| Evaluate the immunogenicity of single and multiple SRK-439 SC dose administration in healthy adult participants | Up to 32 weeks | Incidence of ADAs against SRK-439 in serum |
Countries
United States
Contacts
CONTACTScholar Rock, Inc. Clinical Trials Administration
Outcome results
None listed