Clinical Trial

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease

Recruiting Phase 1
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Record status
This record was last updated March 6, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in healthy adult male and female subjects. In addition, safety, tolerability, PK, and pilot efficacy biomarkers will be evaluated in subjects with cold agglutinin disease (CAD).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-04-07; most recent amendment 2026-03-04.
Trial Details
NCT Number NCT05318534
Lead Sponsor Gliknik Inc.
Conditions First in Man Study to Evaluate Initial Safety
Enrollment 70 participants
Start Date 2022-04-08
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-06