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Clinical Trial Details

Trial ID: L2795
Source ID: NCT05983289
Associated Drug: Hsk7653
Title: Single Escalating Dose Study Of HSK7653 In Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: T2DM (Type 2 Diabetes Mellitus)
Interventions: DRUG: HSK7653|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements., First dose of study drug up to 29 days after last dose of study drug | Secondary: Area Under the Curve From Time Zero to Last Quantifiable Concentration, Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast), Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;|Maximum Observed Plasma Concentration (Cmax), Maximum Observed Plasma Concentration (Cmax), Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;|Time to Reach Maximum Observed Plasma Concentration (Tmax), Time to Reach Maximum Observed Plasma Concentration (Tmax), Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;|Plasma Decay Half-Life (t1/2), Plasma decay half-life is the time measured for the plasma concentration to decrease by one half., Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;|Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration, Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration, Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Sponsor/Collaborators: Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 62
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-05-08
Completion Date: 2019-07-03
Results First Posted:
Last Update Posted: 2023-08-09
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100032, China
URL: https://clinicaltrials.gov/show/NCT05983289