Status: Recruiting
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
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).
Participants needed: 70
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Gliknik Inc.Updated: Mar 6, 2026Locations: 1
Eligibility criteria
Healthy female or male subjects who, at the time of screening, are between the a... [+13]
History of any clinically significant (as determined by the investigator) cardia... [+13]