Study S003299

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

ClinicalTrials.gov record

Registration

Registration: NCT06423872
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 28
Start: 2023-06-19
Primary completion: 2023-10-20
Lead sponsor: Beijing QL Biopharmaceutical Co.,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 50 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 50 days]

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