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RECRUITING
NCT07043946
PHASE1/PHASE2

A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)

Sponsor: Climb Bio, Inc.

View on ClinicalTrials.gov

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

DRUG

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