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A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Sponsor: Climb Bio, Inc.
Summary
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Official title: A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-07-10
Completion Date
2027-04
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Budoprutug
Single IV dose of study product on Day 1 of study
Locations (18)
Climb Bio Investigative Site #100104
Allen, Texas, United States
Climb Bio Investigative Site #100101
San Antonio, Texas, United States
Climb Bio Investigative Site# 359101
Plovdiv, Bulgaria
Climb Bio Investigative Site# 359102
Sofia, Bulgaria
Climb Bio Investigative Site #995102
Tbilisi, Georgia
Climb Bio Investigative Site #995101
Tbilisi, Georgia
Climb Bio Investigative Site# 300102
Exochi, Thessaloniki, Greece
Climb Bio Investigative Site# 300103
Thessaloniki, Thessaloniki, Greece
Climb Bio Investigative Site #100103
Caguas, Puerto Rico
Climb Bio Investigative Site# 400101
Cluj-Napoca, Romania
Climb Bio Investigative Site# 340101
Sabadell, Barcelona, Spain
Climb Bio Investigative Site# 340102
A Coruña, Spain
Climb Bio Investigative Site #380102
Ivano-Frankivsk, Ukraine
Climb Bio Investigative Site #380103
Kyiv, Ukraine
Climb Bio Investigative Site #380106
Kyiv, Ukraine
Climb Bio Investigative Site #380101
Ternopil, Ukraine
Climb Bio Investigative Site #380104
Vinnytsia, Ukraine
Climb Bio Investigative Site #380105
Vinnytsia, Ukraine