A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy … (NCT07090655) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers
Australia38 participantsStarted 2025-08-11
Plain-language summary
The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.
Who can participate
Age range18 Years – 50 Years
SexALL
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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)
What they're measuring
1
Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants
Timeframe: Day 57
2
Incidence of infusion-related reactions (IRRs) for IV administration
Timeframe: Day 57
3
Incidence of injection site reactions (ISRs) for SC administration