A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorScholar Rock, Inc.
About this trial
A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Placebo
- SRK-439
- SRK-439
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov