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

Summary

XW003 is an acylated human GLP-1 analogue and is being development for diabetes mellitus, obesity and nonalcoholic steatohepatitis (NASH) management. This is a first-in-human (FIH), single-centre, double blind, randomised, SAD and MAD study of XW003 conducted in healthy adult participants. The study is designed to evaluate the safety, tolerability, PK, and PD of XW003 in healthy adult participants.

Conditions

• Type 2 Diabetes Mellitus
• Obesity
• Nonalcoholic 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.

Sponsors & Collaborators

• Hangzhou Sciwind Biosciences Co., Ltd.

  collaborator INDUSTRY

• Sciwind Biosciences APAC CO Pty. Ltd.

  lead INDUSTRY

Principal Investigators

• Benjamin Snyder · Nucleus Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-29

Primary Completion

2021-09-29

Completion

2021-09-29

Countries

• Australia

Study Locations