Status and phase
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Study type
Funder types
Identifiers
About
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).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria for Cohorts 1 to 7
Inclusion Criteria for Cohort 8
Exclusion Criteria for Cohorts 1 to 7
Exclusion Criteria for Cohort 8
Other protocol defined inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
57 participants in 2 patient groups, including a placebo group
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Central trial contact
Gliknik Clinical Trials Group
Data sourced from clinicaltrials.gov
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