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A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
Sponsor: Climb Bio, Inc.
Summary
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Official title: A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-06-30
Completion Date
2028-08
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
Budoprutug
Single IV dose of study product on Day 1 and Day 15
Locations (20)
Climb Bio Investigative Site #359202
Plovdiv, Bulgaria
Climb Bio Investigative Site #359203
Plovdiv, Bulgaria
Climb Bio Investigative Site #359201
Sofia, Bulgaria
Climb Bio Investigative Site #300204
Athens, Attica, Greece
Climb Bio Investigative Site #300203
Chaïdári, Attica, Greece
Climb Bio Investigative Site #300202
Ioannina, Greece
Climb Bio Investigative Site #300201
Thessaloniki, Greece
Climb Bio Investigative Site #381201
Belgrade, Serbia
Climb Bio Investigative Site #381202
Belgrade, Serbia
Climb Bio Investigative Site #381203
Novi Sad, Serbia
Climb Bio Investigative Site #340206
Burgos, Spain
Climb Bio Investigative Site #340204
Madrid, Spain
Climb Bio Investigative Site #340202
San Pedro, Spain
Climb Bio Investigative Site #340203
Valencia, Spain
Climb Bio Investigative Site #380208
Cherkasy, Ukraine
Climb Investigative Site #380204
Ivano-Frankivsk, Ukraine
Climb Investigative Site #2380203
Kyiv, Ukraine
Climb Investigative Site #380202
Kyiv, Ukraine
Climb Investigative Site #380206
Kyiv, Ukraine
Climb Investigative Site #380201
Lviv, Ukraine