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)
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged 18 years at the time of consent.
• Platelet count \< 30,000/µL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of \< 30,000/µL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart.
• Partial thromboplastin time \< 1.5 x upper limit of normal (ULN), prothrombin time \< 1.5 x ULN, total bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio \< 1.5 at screening.
Locations
Other Locations
Bulgaria
Climb Bio Investigative Site #359202
RECRUITING
Plovdiv
Climb Bio Investigative Site #359203
RECRUITING
Plovdiv
Climb Bio Investigative Site #359201
RECRUITING
Sofia
Greece
Climb Bio Investigative Site #300204
RECRUITING
Athens
Climb Bio Investigative Site #300203
RECRUITING
Chaïdári
Climb Bio Investigative Site #300202
RECRUITING
Ioannina
Climb Bio Investigative Site #300201
RECRUITING
Thessaloniki
Serbia
Climb Bio Investigative Site #381201
RECRUITING
Belgrade
Climb Bio Investigative Site #381202
RECRUITING
Belgrade
Climb Bio Investigative Site #381203
RECRUITING
Novi Sad
Spain
Climb Bio Investigative Site #340206
NOT_YET_RECRUITING
Burgos
Climb Bio Investigative Site #340204
RECRUITING
Madrid
Climb Bio Investigative Site #340202
RECRUITING
San Pedro
Climb Bio Investigative Site #340203
RECRUITING
Valencia
Ukraine
Climb Bio Investigative Site #380208
NOT_YET_RECRUITING
Cherkasy
Climb Investigative Site #380204
RECRUITING
Ivano-frankivsk
Climb Investigative Site #2380203
RECRUITING
Kyiv
Climb Investigative Site #380202
RECRUITING
Kyiv
Climb Investigative Site #380206
RECRUITING
Kyiv
Climb Investigative Site #380201
RECRUITING
Lviv
Contact Information
Primary
Climb Bio Study Director
clinicaltrials@climbbio.com
+1 866 857 2596
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2028-08
Participants
Target number of participants: 24
Treatments
Experimental: Cohort 1: Dose Level A
Single IV dose of study product on Day 1 and on Day 15
Experimental: Cohort 2: Dose Level B
Single IV dose of study product on Day 1 and on Day 15
Experimental: Cohort 3: Dose Level C
Single IV dose of study product on Day 1 and on Day 15
Experimental: Dose Expansion Cohort
Single IV dose of study product on Day 1 and Day 15
Related Therapeutic Areas
Sponsors
Leads: Climb Bio, Inc.