A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers
The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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)
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
BASIC_SCIENCE
Phase
- EARLY_PHASE1
Study ID
NCT07090655
Intervention or treatment
DRUG: Budoprutug
DRUG: Placebo
Conditions
- Healthy Volunteers
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Research sites nearby
Closest Location:
Nucleus Network Brisbane
Select from list below to view details:
Nucleus Network Brisbane
Brisbane, Australia
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Who is running the clinical trial?
Climb Bio, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Budoprutug
| Drug: Budoprutug |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Measurement of the maximum observed plasma concentration. | Day 57 |
| Time to Maximum Observed Concentration (Tmax) | Measurement of the time to maximum observed concentration. | Day 57 |
| Area Under the Curve (AUC) | Measurement of the area under the drug concentration-time curve. | Day 57 |
| Terminal Half-Life (T1/2) | Measurement of the terminal half-life in days. | Day 57 |
| Bioavailability (F) | Relative absorption of SC vs IV budoprutug (%). | Day 57 |
References
Clinical Trials Gov: A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy VolunteersOther trials to consider
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