Study S003356

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Assess Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT05579314
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 127
Start: 2022-09-26
Primary completion: 2024-11-16
Lead sponsor: Sciwind Biosciences USA Co., Ltd.
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:XW014; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE) [11 weeks]
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities [11 weeks]

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