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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Scholar Rock, Inc.
Study ID
NCT07444294
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 21, 2025
Status verified
Feb 2026
Primary completion
Dec 17, 2026
Completion
Jun 9, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Participants will be treated with a single dose of SRK-439 or matching placebo.
  • Experimental: Part B
    Participants will be treated with multiple doses of SRK-439 or matching placebo.

Primary Outcome Measure

Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medpace CPUCincinnatiOhio45227-

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By research site
Medpace CPU· Cincinnati, OH

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