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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Budoprutug; Drug: Placebo

• Registration Number: NCT07090655
• Lead Sponsor: Climb Bio, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Study First Posted: 2025-07-29
• Status Verified: 2025-08
• Study Start: 2025-08-11
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-08-20
• Primary Completion: 2026-04
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Healthy adult males and females aged 18-60 years
• Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg
• Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant)
• Willing and able to comply with study procedures and provide informed consent
• Women of childbearing potential must use highly effective contraception and have negative pregnancy tests
• Men must use contraception and refrain from sperm donation for 6 months post-dose
• Completion of a 2-dose primary COVID-19 vaccination series and at least 1 booster dose, as well as influenza vaccination (within 12 months)

Exclusion Criteria

• Prior treatment with investigational drugs within 30 days or 5 half-lives
• History of hypogammaglobulinemia or significant allergic reactions
• Recent infections, including serious local/systemic infections or opportunistic infections
• Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis
• Use of tobacco (>2 cigarettes/day), alcohol abuse, or recreational drugs
• Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Budoprutug	Budoprutug	Subcutaneous (SC) injection or IV administration of budoprutug
Placebo	Placebo	Placebo solution to be administered at a matching volume

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants	Day 57	Incidence of treatment-emergent adverse events
Incidence of infusion-related reactions (IRRs) for IV administration	Day 57	Number of infusion-related reactions
Incidence of injection site reactions (ISRs) for SC administration	Day 57	Number of injection site reactions

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Observed Concentration (Tmax)	Day 57	Measurement of the time to maximum observed concentration.
Area Under the Curve (AUC)	Day 57	Measurement of the area under the drug concentration-time curve.
Terminal Half-Life (T1/2)	Day 57	Measurement of the terminal half-life in days.
Bioavailability (F)	Day 57	Relative absorption of SC vs IV budoprutug (%).
Maximum Observed Plasma Concentration (Cmax)	Day 57	Measurement of the maximum observed plasma concentration.

Trial Locations

Locations (2)

Nucleus Network Brisbane; 🇦🇺 Brisbane, Australia

Nucleus Network Brisbane; 🇦🇺 Brisbane, Australia