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

Registration

Registration

NCT05491421

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

QUADRUPLE

Status

COMPLETED

Enrollment

32

Start

2022-09-02

Primary completion

2023-04-28

Lead sponsor

QL Biopharmaceutical Australia Pty Ltd

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG:ZT002; OTHER:Placebo

Results posted

FALSE

Registered primary outcomes

• Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events. [Up to 71 days]
• Safety and tolerability of a single escalation dose of ZT002 through the incidence severity of serious adverse events in SAD Cohorts. Number of participants with serious adverse events. [Up to 71 days]
• To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through number of participants with treatment emergent adverse events in MAD Cohorts. [up to 85 days]
• To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through incidence severity of serious adverse events in MAD Cohorts. [Upto 85 days]