To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Type 2 Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: one of up to seven (7) sequential cohorts (Cohorts A1 to A7). Participants in each cohort will be randomised to receive a single subcutaneous (SC) dose of either XW003 or matching placebo on Day 1 following an overnight fast. Two sentinel participants will receive a single SC dose of XW003 initially. If dosing of these sentinel participants proceeds without clinically significant safety signals in the first 48 hours post-dose, the remaining participants will receive a single dose of XW003 or placebo according to the randomisation schedule.Masking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
Participants will undergo a Screening period beginning up to 28 days prior to randomisation/dose administration. Participants will undergo pre-dose assessments, post-dose assessments, and will complete an EOS follow-up visit or early termination (ET) visit. Up to 50 participants will be enrolled int...
Participants will undergo a Screening period beginning up to 28 days prior to randomisation/dose administration. Participants will undergo pre-dose assessments, post-dose assessments, and will complete an EOS follow-up visit or early termination (ET) visit. Up to 50 participants will be enrolled into one of up to seven (7) sequential cohorts (Cohorts A1 to A7). Participants in each cohort will be randomised to receive a single subcutaneous (SC) dose of either XW003 or matching placebo on Day 1 following an overnight fast. Two sentinel participants will receive a single SC dose of XW003 initially. If dosing of these sentinel participants proceeds without clinically significant safety signals in the first 48 hours post-dose, the remaining participants will receive a single dose of XW003 or placebo according to the randomisation schedule.
Tracking Information
- NCT #
- NCT04389775
- Collaborators
- Novotech (Australia) Pty Limited
- Investigators
- Not Provided
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