Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
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.
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 ;
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