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Healthy volunteers needed to test safety of experimental drug budoprutug

NCT ID NCT07090655

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This early-phase study tests the safety of a new drug, budoprutug, in 38 healthy adults aged 18-60. Participants receive either the drug or a placebo by injection or IV. The goal is to check for side effects and how the drug moves through the body, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

30 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Nucleus Network Brisbane

    Brisbane, Australia

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