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

NCT07090655 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: TNT119-NHV-101
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

healthy; volunteer

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants

  Incidence of treatment-emergent adverse events

  Day 57

• Incidence of infusion-related reactions (IRRs) for IV administration

  Number of infusion-related reactions

  Day 57

• Incidence of injection site reactions (ISRs) for SC administration

  Number of injection site reactions

  Day 57

Secondary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax)

  Day 57

• Time to Maximum Observed Concentration (Tmax)

  Day 57

• Area Under the Curve (AUC)

  Day 57

• Terminal Half-Life (T1/2)

  Day 57

• Bioavailability (F)

  Day 57

Study Arms (2)

Budoprutug

EXPERIMENTAL

Subcutaneous (SC) injection or IV administration of budoprutug

Drug: Budoprutug

Placebo

PLACEBO COMPARATOR

Placebo solution to be administered at a matching volume

Drug: Placebo

Interventions

Budoprutug DRUG

Subcutaneous or IV administration

Also known as: TNT119

Budoprutug

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Climb Bio, Inc.: lead

Study Sites (1)

Nucleus Network Brisbane

Brisbane, Australia

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: August 11, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

AU (1)