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

Climb Bio, Inc.

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Budoprutug

Study type: Interventional

Funder types: Industry

Identifiers

NCT07090655

TNT119-NHV-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Budoprutug

Experimental group

Description:

Subcutaneous (SC) injection or IV administration of budoprutug

Treatment:

Drug: Budoprutug

Placebo

Placebo Comparator group

Description:

Placebo solution to be administered at a matching volume

Treatment:

Drug: Placebo