NCT07090655

A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Injections of Budoprutug (TNT119) in Normal Healthy Volunteers

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Climb Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.

Detailed description

Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of budoprutug administered subcutaneously (SC) in adult normal healthy volunteers (NHVs). To assess the bioavailability of the SC formulation, one cohort will receive a single intravenous (IV) dose of budoprutug. Approximately 38 participants will be enrolled across four dose cohorts, including three SC dose levels and one IV comparator group.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Budoprutug	Subcutaneous or IV administration
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2025-08-11
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2025-07-29
• Last updated: 2026-03-13

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study