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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate Safety and PK of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults

NCT03046550

Healthy

COMPLETED PHASE1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults

NCT04629131

Healthy Adult Subjects

COMPLETED PHASE1

A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

NCT05655221

Nonalcoholic Steatohepatitis

UNKNOWN PHASE1

A Safety and Tolerability Study of BPR-30221616 Injection in Healthy Subjects

NCT06760455

Healthy Participants

RECRUITING PHASE1

Study of TAVO101 in Healthy Volunteers

NCT05298046

Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Budoprutug

Subcutaneous (SC) injection or IV administration of budoprutug

Group Type EXPERIMENTAL

Budoprutug

Intervention Type DRUG

Subcutaneous or IV administration

Placebo

Placebo solution to be administered at a matching volume

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Budoprutug

Subcutaneous or IV administration

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TNT119

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes