Healthy VolunteersEarly Phase 1NCT07090655
A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers
A Early Phase 1 study testing Budoprutug in people with Healthy Volunteers, run by Climb Bio, Inc. at 1 site in Australia.
Trial summary
The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Budoprutug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Aug 2025to 7 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.
Read the detailed description
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
- Healthy Volunteers
- Being tested
- Budoprutug, Placebo
- Keywords
- healthy, volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudoprutugDrug
Also called TNT119
Subcutaneous or IV administration
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Budoprutug | Experimental | Subcutaneous (SC) injection or IV administration of budoprutug Receives: Drug: Budoprutug |
| Placebo | Placebo comparator | Placebo solution to be administered at a matching volume Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants
Incidence of treatment-emergent adverse events
Measured: Day 57
Incidence of infusion-related reactions (IRRs) for IV administration
Number of infusion-related reactions
Measured: Day 57
Incidence of injection site reactions (ISRs) for SC administration
Number of injection site reactions
Measured: Day 57
Secondary outcomes (5)
Maximum Observed Plasma Concentration (Cmax)
Measurement of the maximum observed plasma concentration.
Measured: Day 57
Time to Maximum Observed Concentration (Tmax)
Measurement of the time to maximum observed concentration.
Measured: Day 57
Area Under the Curve (AUC)
Measurement of the area under the drug concentration-time curve.
Measured: Day 57
Terminal Half-Life (T1/2)
Measurement of the terminal half-life in days.
Measured: Day 57
Bioavailability (F)
Relative absorption of SC vs IV budoprutug (%).
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start11 Aug 2025
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Climb Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090655
- Sponsor's protocol ID
- TNT119-NHV-101
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07090655
- Acronym / sponsor ID
- TNT119-NHV-101
- Conditions
- Healthy Volunteers
- Keywords
- healthy, volunteer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Climb Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budoprutug | Experimental | Drug: BudoprutugSubcutaneous (SC) injection or IV administration of budoprutug |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution to be administered at a matching volume |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudoprutugAlso: TNT119Subcutaneous or IV administration | Drug | Budoprutug |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants
Time frame: Day 57
Incidence of treatment-emergent adverse events
Incidence of infusion-related reactions (IRRs) for IV administration
Time frame: Day 57
Number of infusion-related reactions
Incidence of injection site reactions (ISRs) for SC administration
Time frame: Day 57
Number of injection site reactions
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 57
Time to Maximum Observed Concentration (Tmax)
Time frame: Day 57
Area Under the Curve (AUC)
Time frame: Day 57
Terminal Half-Life (T1/2)
Time frame: Day 57
Bioavailability (F)
Time frame: Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Budoprutug in people with Healthy Volunteers, run by Climb Bio, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants (time frame: Day 57). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.