BW-20805: Cohort 1 will receive SC administrations of BW-20805 on Day1.
BW-20805: Group 2 will receive SC administrations of BW-20805 on Day1
BW-20805-2: Group 3 will receive SC administrations of BW-20805-2 on Day1.
Study summary
A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Primary Endpoints — week 48 Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Trial sites (1)
Facility
City
Region
Status
Argo Investigative Site
Melbourne
Victoria
More Shanghai Argo Biopharmaceutical Co., Ltd. trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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