HV
Conditions
Brief summary
A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants
Detailed description
A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants
Interventions
DRUGBW-20805
Cohort 1 will receive SC administrations of BW-20805 on Day1.
DRUGBW-20805-2
Group 3 will receive SC administrations of BW-20805-2 on Day1.
Sponsors
Shanghai Argo Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoints | week 48 | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoints | week 48 | Maximum observed plasma concentration (Cmax), - Time to maximum plasma concentration (Tmax), |
Countries
Australia
Contacts
CONTACTManxue Jia
CONTACTYan NA Yang
Outcome results
None listed