A Phase 1 Clinical Study of BW-20805-2-1001 in Healthy Participants (NCT07528053) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1 Clinical Study of BW-20805-2-1001 in Healthy Participants
Australia24 participantsStarted 2026-04-28
Plain-language summary
A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants
Who can participate
Age range18 Years – 60 Years
SexALL
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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 (whi…