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A Study of HL40626S Tablets in Healthy Adults

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 1 → 3 primary endpoints
See other at-risk trials from HighsLab Therapeutics Inc.

Record History

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  1. Notable Primary endpoint(s) modifiedv3 Show 7 more changesShow less
    • Sponsor changed: Highslab Therapeutics, Inc. to HighsLab Therapeutics Inc.
    • Primary completion date: Feb 16, 2027 to Feb 2027
    • Study completion date: May 23, 2027 to May 2027
    • Start date: Aug 16, 2026 to Aug 2026
    • Eligibility criteria shortened, about 184 words
    • Secondary endpoints: 18 to 5
    • Study description shortened, about 107 words
  2. Notable Primary endpoints: 1 to 3v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.
Trial Details
NCT Number NCT07736586
Lead Sponsor HighsLab Therapeutics Inc.
Conditions
(from sponsor)
Psoriasis (PsO), Skin Disease, Immune System Disease, Skin Diseases, Papulosquamous
Related terms Immune System Diseases, Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov