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A Study to Evaluate the Safety, Tolerability and PK of SK-09

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Oct 4, 2026 → Apr 30, 2027
See other at-risk trials from Consun Pharmaceutical Group

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 4, 2026 to Apr 30, 2027
    • Enrollment increased: 72 → 84 participants
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description expanded, about 34 words
    v4
  2. Primary and study completion pushed from Aug 31, 2026 to Oct 4, 2026
    • Secondary endpoints: details revised at 5 of 5 entries
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2025 to Dec 8, 2025
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 1 trial consists of three parts: Part 1 is a Single Ascending Dose (SAD) study, Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design. Part 3 is a randomized, open-label, single-dose, two-period crossover self-controlled design FE study.
Trial Details
NCT Number NCT07267026
Lead Sponsor Consun Pharmaceutical Group
Conditions
(from sponsor)		 FSGS, MCD
Related terms Macular dystrophy, corneal type 1
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov