To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

March 29, 2020

Primary Completion Date

September 29, 2021

Study Completion Date

September 29, 2021

Conditions
Type 2 Diabetes MellitusObesityNonalcoholic Steatohepatitis
Interventions
DRUG

Cohort A

"Participants in each cohort (A1 to A6) will be randomised to receive a SC dose of XW003 on Day 1 after overnight fasting by body weight range:~1. Proposed XW003 Dose Levels (50 kg-75 kg): 0.03mg, 0.1mg, 0.2mg, 0.4mg, 0.8mg and 0.6mg respectively for Cohorts A1 to A6.~2. Proposed XW003 Dose Levels (76 kg-90 kg): 0.03mg, 0.1mg, 0.25mg, 0.5mg, 1.0 mg and 0.6mg.~These doses are subject to change following SRC review of each cohort - XW003 dose level will not exceed 2.0 mg."

DRUG

Placebo A

"Participants in each cohort (A1 to A6) will be randomised to receive a SC dose of volume-matching placebo on Day 1 after overnight fasting by body weight range:~1. Proposed Placebo Dose Levels (50 kg-75 kg): 0.03mg, 0.1mg, 0.2mg, 0.4mg, 0.8mg, and 0.6mg respectively for Cohorts A1 to A6.~2. Proposed Placebo Dose Levels (76 kg-90 kg): 0.03mg, 0.1mg, 0.25mg, 0.5mg, 1.0 mg and 0.6mg.~These doses are subject to change following SRC review of each cohort - dose level will not exceed 2.0 mg."

DRUG

Cohort B

"Participants in cohorts B1 to B3 (n=10 per cohort) will receive multiple SC doses of XW003 (n=8) once weekly for 6 weeks following an overnight fast of at least 10 hours.~1. Subject to change following SRC review of each cohort.~2. Following 4 weeks of once weekly dosing, the SRC will review the safety data (and PK data for Cohort B1 only) to determine the treatment for the following cohort and whether dosing can commence in parallel.~3. At least 3 days prior to Cohort B3 Week 3 (i.e., 3 days prior to the third dose in Cohort B3), the SRC will review the safety and PK data for Cohorts B1 and B2 to determine whether Cohort 3 dosing for Weeks 3 to 6 may commence."

DRUG

Placebo B

"Participants in cohorts B1 to B3 (n=10 per cohort) will receive multiple SC doses of matching placebo (n=2) once weekly for 6 weeks following an overnight fast of at least 10 hours.~1. Subject to change following SRC review of each cohort.~2. Following 4 weeks of once weekly dosing, the SRC will review the safety data (and PK data for Cohort B1 only) to determine the treatment for the following cohort and whether dosing can commence in parallel.~3. At least 3 days prior to Cohort B3 Week 3 (i.e., 3 days prior to the third dose in Cohort B3), the SRC will review the safety and PK data for Cohorts B1 and B2 to determine whether Cohort 3 dosing for Weeks 3 to 6 may commence."

Trial Locations (1)

3004

Nucleus Network Pty Ltd, Melbourne

All Listed Sponsors
collaborator

Hangzhou Sciwind Biosciences Co., Ltd.

INDUSTRY

lead

Sciwind Biosciences APAC CO Pty. Ltd.

INDUSTRY

NCT04389775 - To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants | Biotech Hunter | Biotech Hunter