Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11

StatusNot Yet Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Dec 31, 2026 → Jan 31, 2027
See other at-risk trials from Shanghai Henlius Biotech

Record History

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  1. Start date pushed from Nov 5, 2026 to Nov 15, 2026
    • Study sites: 0 to 1
  2. Start date: Sep 5, 2026 to Nov 5, 2026 Show 4 more changesShow less
    • Primary completion pushed from Dec 31, 2026 to Jan 31, 2027
    • Study sites: 1 to 0
    • Study completion date: Feb 1, 2027 to Mar 1, 2027
    • Eligibility criteria expanded, about 13 words
  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.
This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult participants.
Trial Details
NCT Number NCT07776132
Lead Sponsor Shanghai Henlius Biotech
Conditions
(from sponsor)		 Health Adult Subjects
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov