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

PHASE1RecruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

April 8, 2022

Primary Completion Date

January 21, 2026

Study Completion Date

January 21, 2026

Conditions

First in Man Study to Evaluate Initial Safety

Interventions

DRUG

GL-0719

Administration route: intravenous infusion and subcutaneous injection

DRUG

Placebo

Administration route: intravenous infusion and subcutaneous injection

Trial Locations (1)

RECRUITING

Fortrea Clinical Research Unit Ltd, Leeds