New drug BW-20805-2 put to the test in healthy volunteers
NCT ID NCT07528053
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Argo Investigative Site
Melbourne, Victoria, 3004, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.