A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males

Sponsor
siRNAgen Therapeutics Inc.
Study ID
NCT07407543
Phase
PHASE1
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
MALE
Age
19 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • SRN001 — DRUG
    SRN001 is an investigational drug administered at doses of 45 mg, 90 mg, or 180 mg depending on cohort.
  • 0.9% sodium chloride (normal saline) — DRUG
    0.9% sodium chloride solution administered as placebo control.

Study Details

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of SRN001 in healthy adult volunteers.

Key Dates

First listed
Feb 12, 2026
Start date
Jan 5, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: cohort1 Drug: SRN001 45mg
    cohort1 Drug: SRN001 45mg
  • Experimental: cohort2 Drug: SRN001 90mg
    cohort2 Drug: SRN001 90mg
  • Experimental: cohort3 Drug: SRN001 180mg
    cohort3 Drug: SRN001 180mg
  • Placebo Comparator: Placebo Comparator
    Participants receive placebo (0.9% sodium chloride, normal saline)

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose through end of study (up to 114 days) ]

Central Contacts

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