Clinical Trial

Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants

Recruiting Phase 1
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Record status
This record was last updated September 19, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.
Trial Details
NCT Number NCT07182656
Lead Sponsor Yi Fang
Conditions Rheumatoid Arthritis (RA)
Enrollment 70 participants
Start Date 2025-08-18
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-19