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New drug BW-20805-2 put to the test in healthy volunteers

NCT ID NCT07528053

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tests a single dose of an experimental drug called BW-20805-2 in 24 healthy adults aged 18 to 60. The main goal is to check for side effects and see how the drug moves through the body. Participants receive one injection under the skin and are monitored for safety. This study does not aim 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

Phase 1

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

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

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 60 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: * Must have given written informed consent and be able to comply with all study requirements * Males or females aged 18 to 60 years old, inclusive, at the time of informed consent. * Body mass index (BMI) ≥18 and ≤32 kg/m2 and body weight ≥50 kg Female participants must be non-pregnant * Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 48 weeks following administration of the study drug Exclusion Criteria: * Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that * Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site * Hospitalization for any reason within 60 days prior to screening. * Presence of carcinoma and history of carcinoma * Any clinically significant acute condition * Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after at least 5 minutes resting * Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening * Participants with ANY in clinical laboratory tests at screening or Day-1. * History of bleeding diathesis or clinically significant hemorrhagic disorders Positive for hepatitis B surface antigen * Single 12-lead ECG with clinically significant abnormalities at screening or Day -1 * Use of an investigation agent or device within 30 days or 5 half-lives (whichever is longer) before the study drug administration. * Used prescription drugs, excluding hormonal contraceptives * Used over-the-counter (OTC) medications * Have received treatment with small interfering RNA (siRNA) within the last 12 months * History of allergic reactions to synthetic siRNA or GalNAc and/or any other clinically significant allergic reactions. * Use of more than 10 tobacco/nicotine containing products or equivalent per day within 30 days prior to screening and not willing to abstain for 48 hours prior to admission to the unit * History or clinical evidence of alcohol substance abuse, within the 12 months before screening * History or clinical evidence of drug abuse, within the 12 months before screening * Positive test for alcohol or drugs of abuse at screening or Day -1 * Have received vaccination with a live vaccine * Donated or lost \>200 mL of blood or plasma within 30 days prior to screening * Any conditions which, in the opinion of the Investigator

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Argo Investigative Site

    Melbourne, Victoria, 3004, Australia

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