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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07090655




Registration number
NCT07090655
Ethics application status
Date submitted
21/07/2025
Date registered
29/07/2025
Date last updated
20/08/2025

Titles & IDs
Public title
A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers
Scientific title
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
Secondary ID [1] 0 0
TNT119-NHV-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Budoprutug
Treatment: Drugs - Placebo

Experimental: Budoprutug - Subcutaneous (SC) injection or IV administration of budoprutug

Placebo comparator: Placebo - Placebo solution to be administered at a matching volume


Treatment: Drugs: Budoprutug
Subcutaneous or IV administration

Treatment: Drugs: Placebo
Placebo comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants
Timepoint [1] 0 0
Day 57
Primary outcome [2] 0 0
Incidence of infusion-related reactions (IRRs) for IV administration
Timepoint [2] 0 0
Day 57
Primary outcome [3] 0 0
Incidence of injection site reactions (ISRs) for SC administration
Timepoint [3] 0 0
Day 57
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [1] 0 0
Day 57
Secondary outcome [2] 0 0
Time to Maximum Observed Concentration (Tmax)
Timepoint [2] 0 0
Day 57
Secondary outcome [3] 0 0
Area Under the Curve (AUC)
Timepoint [3] 0 0
Day 57
Secondary outcome [4] 0 0
Terminal Half-Life (T1/2)
Timepoint [4] 0 0
Day 57
Secondary outcome [5] 0 0
Bioavailability (F)
Timepoint [5] 0 0
Day 57

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Brisbane - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Climb Bio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Climb Bio Study Director
Address 0 0
Country 0 0
Phone 0 0
+1 866 857 2596
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07090655