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 — DRUG
    Single 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

Locations (2)

FacilityCityStateZIPSite coordinators
Climb Bio Investigative Site #100104AllenTexas75013-
Climb Bio Investigative Site #100101San AntonioTexas78215-

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