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)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Aged 18 to 65 years at the time of consent.
• Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
• Active, seropositive disease, with SLEDAI 2K \>=8.
• Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.
Locations
United States
Texas
Climb Bio Investigative Site #100101
RECRUITING
San Antonio
Other Locations
Bulgaria
Climb Bio Investigative Site# 359101
RECRUITING
Plovdiv
Climb Bio Investigative Site# 359102
RECRUITING
Sofia
Greece
Climb Bio Investigative Site# 300102
NOT_YET_RECRUITING
Exochi
Climb Bio Investigative Site# 300103
NOT_YET_RECRUITING
Thessaloniki
Puerto Rico
Climb Bio Investigative Site #100103
RECRUITING
Caguas
Romania
Climb Bio Investigative Site# 400101
RECRUITING
Cluj-napoca
Spain
Climb Bio Investigative Site# 340102
NOT_YET_RECRUITING
A Coruña
Climb Bio Investigative Site# 340101
NOT_YET_RECRUITING
Sabadell
Ukraine
Climb Bio Investigative Site #380102
RECRUITING
Ivano-frankivsk
Climb Bio Investigative Site #380103
RECRUITING
Kyiv
Climb Bio Investigative Site #380106
RECRUITING
Kyiv
Climb Bio Investigative Site #380101
RECRUITING
Ternopil
Climb Bio Investigative Site #380104
RECRUITING
Vinnytsia
Climb Bio Investigative Site #380105
RECRUITING
Vinnytsia
Contact Information
Primary
Climb Bio Study Director
clinicaltrials@climbbio.com
+1 866 857 2596
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2027-04
Participants
Target number of participants: 30
Treatments
Experimental: Cohort 1: Dose Level A
Experimental: Cohort 2: Dose Level B
Experimental: Cohort 3: Dose Level C
Experimental: Cohort 4: Dose Level D
Related Therapeutic Areas
Sponsors
Leads: Climb Bio, Inc.