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Clinical Trial Details

Trial ID: L5307
Source ID: NCT04790006
Associated Drug: Tg103
Title: A Study of TG103 in Subjects With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: TG103|DRUG: Placebo
Outcome Measures: Primary: Safety and tolerability assessed by incidence and severity of adverse events, A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module, up to 15 weeks | Secondary: Area under the plasma concentration versus time curve (AUC), PK parameters after administration of of TG103, Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78|glycosylated hemoglobin (HbA1c), Pharmacodynamic (PD) parameters after administration of of TG103, Day15, 29, 43, 57,71, and 78,|The occurrence of TG103 anti-drug antibodies (ADA), AD Aafter administration of of TG103, up to 15 weeks|Peak Plasma Concentration (Cmax),, PK parameters after administration of of TG103, Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78|Time to maximum plasma concentration (Tmax), PK parameters after administration of of TG103, Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78|Half time (t1/2),, PK parameters after administration of of TG103, Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78|Apparent clearance (CL/F), PK parameters after administration of of TG103, Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Sponsor/Collaborators: Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 54
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-04
Completion Date: 2022-03
Results First Posted:
Last Update Posted: 2021-03-10
Locations:
URL: https://clinicaltrials.gov/show/NCT04790006