A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Part of paid clinical trials in Allen, Texas.
- Sponsor
- Climb Bio, Inc.
- Study ID
- NCT07011043
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Budoprutug — DRUGSingle IV dose of study product on Day 1 of study
Study Details
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.
Key Dates
- Start date
- Jul 10, 2025
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: Dose Level A
- Experimental: Cohort 2: Dose Level B
- Experimental: Cohort 3: Dose Level C
- Experimental: Cohort 4: Dose Level D
Primary Outcome Measure
Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 24 ]
Central Contacts
- Climb Bio Study Director+1 866 857 2596
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Climb Bio Investigative Site #100104 | Allen | Texas | 75013 | - |
| Climb Bio Investigative Site #100101 | San Antonio | Texas | 78215 | - |
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