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Study identifier: NCT05318534 Synced from ClinicalTrials.gov · July 28, 2026
● 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

Condition: First in Man Study to Evaluate Initial Safety  ·  Sponsor: Gliknik Inc.

PhasePhase 1
Planned participants70
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Gliknik Clinical Trials Group  ·  410-665-0662  ·  gliknikclinicaltrialinquiries@gliknik.com

Always discuss trial participation with your own doctor first.

Locations (1)

Fortrea Clinical Research Unit LtdLeeds, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT05318534