Single-ascending Dose Study of HEC-151 Injection

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 5, 2026 → Dec 31, 2026
See other at-risk trials from Sunshine Lake Pharma Co., Ltd.

Record History

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  1. Primary completion pushed from Sep 5, 2026 to Dec 31, 2026
    • Study completion pushed from Sep 27, 2026 to Jan 31, 2027
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 2 of 9 entries
  2. Recruitment openedv2 Show 4 more changesShow less
    • Trial arms changed: 2 → 3
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 11, 2026 to Feb 24, 2026
    • Interventions: Degludec insulin (Drug), HEC-151 Injection and placebo (Drug) to Degludec insulin (Drug), HEC-151 Injection (Drug), Placebo (Drug)
  3. Study First Submitted
  • 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.
Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
Trial Details
NCT Number NCT07376200
Lead Sponsor Sunshine Lake Pharma Co., Ltd.
Conditions
(from sponsor)		 Healthy Adult Male
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov