Study S003317

A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

ClinicalTrials.gov record

Registration

Registration: NCT07594847
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: RECRUITING
Enrollment: 72
Start: 2026-03-07
Primary completion: 2026-09-25
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Conditions: Healthy Adult Subject
Interventions: DRUG:HDM1002 200 mg; DRUG:HDM1002 400 mg; DRUG:Placebo; DRUG:Moxifloxacin 400 mg
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Correlation between HDM1002 Plasma Concentration and ΔΔQTc [From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose]

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