NCT05491421

A Study of ZT002 in Healthy Participants

A Phase 1, Randomized, Parallel Assignment, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of ZT002 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: QL Biopharmaceutical Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.

Detailed description

This study is planned to be conducted in 2 portions: single ascending dose and multiple ascending doses. For the SAD portion, there are a total of 4 cohorts. In each cohort 6 participants will receive ZT002, and 2 participants will receive placebo, for a total of 8 participants in each cohort. For the MAD portion, the study is planned to be conducted in healthy participants with a BMI range of 26kg/m\^2 to 40kg/m\^2 and a body weight of \>/= 80kg. This portion is planned to be conducted in 3 cohorts (Cohort 1 to 3), 6 participants will receive ZT002, and 2 participants will receive placebo, across of total of 8 participants (for a total of 24 participants across 3 cohorts). In each cohort, 3 escalating doses of ZT002 are planned. Dosing is planned to be administered every 2 weeks (Q2W). Potential participants will be screened to assess their eligibility to enter the study in a Screening period from days -28 to -2, prior to the scheduled treatment on Day 1. A Safety Monitoring Committee (SMC) meeting to discuss dose escalation will be held after each cohort

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ZT002	Participants will receive a single subcutaneous (SC) ZT002 dose of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under fasted conditions. Participants will MAD Cohorts will receive a single subcutaneous (SC) ZT002 in following doses under fasting conditions- * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings
OTHER	Placebo	Participants will receive same volume as of the study drug of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under the fasted condition. Participants in MAD cohorts will receive same volume as study drug in the following cohorts under fasted condition- * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings

Timeline

• Start date: 2022-09-02
• Primary completion: 2023-04-28
• Completion: 2023-04-28
• First posted: 2022-08-08
• Last updated: 2026-01-16

Locations

1 site across 1 country: Australia