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First human tests begin for potential lung and tumor drug

NCT ID NCT05740475

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new drug called 9MW3811 for the first time in humans. The main goal was to check if it is safe and how well it is tolerated in 32 healthy adults aged 18 to 55. Researchers gave a single dose and monitored for side effects, measuring how the drug moves through the body. This early research is a necessary step before testing the drug in people with diseases like pulmonary fibrosis or tumors.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Mar 2023

Finished

Jan 2024

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 55 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: 1. Male or female participants between 18 and 55 years of age, inclusive. 2. Male body weight ≥50.0 kg, or female body weight ≥45.0 kg, and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. 3. In good health determined by the investigator based on a medical evaluation, including a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, laboratory evaluations. Exclusion Criteria: 1. Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities. 2. Having any history of an allergy to biological agents or any components of study drug; those who have a history of allergies and judged by the investigator to be ineligible for enrolment. 3. Use of any prescription medication 14 days prior to dosing or over-the-counter medication, vitamins, and/or herbal medicines 7 days prior to dosing (Excluding oral contraception, occasional paracetamol, ibuprofen and standard dose of multivitamins at the discretion of the PI or designee) 4. Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study 5. Participants who received immunosuppressants except for previous use of inhaled or nasal corticosteroids 4 weeks earlier before administration or any oral corticosteroids 8 weeks earlier before administration, and who had received a single dose of monoclonal antibodies for any reason within 1 year prior to screening 6. Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody 7. History of drug abuse including narcotic and psychiatric drugs within 6 months prior to screening or a positive drug abuse test result at baseline (Morphine, Methamphetamine, Tetrahydrocannabinol acid, Cocaine) 8. Participants with a positive SARS-CoV-2 test prior to admission (polymerase chain reaction (PCR) and/or rapid antigen testing (RAT), per site policy and PI discretion)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Scientia Clinical Research

    Randwick, New South Wales, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.