Clinical trials: Cold Agglutinin Disease
First in Man Study to Evaluate Initial Safety
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…
- Trial name
- NCT05318534
- Testing
- GL-0719
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Gliknik Inc.
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company