Study S002466

A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQF3250 Capsules in Healthy Adult Subjects After Single Administration and Escalating Doses

ClinicalTrials.gov record

Registration

Registration: NCT07327281
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: RECRUITING
Enrollment: 66
Start: 2025-12-18
Primary completion: 2026-12
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions: Hyperglycemia
Interventions: DRUG:TQF3250 placebo; DRUG:TQF3250 capsule
Results posted: FALSE

Registered primary outcomes

Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) [Up to 20 days]
Number of participants with abnormal clinical laboratory test indicators [Up to 20 days]
Changes in body temperature after using TQF3250 capsules [Up to 24 hour]
Tolerance assessment: 12-lead electrocardiogram [Up to 20 days]
Changes in pulse/heart rate after use of TQF3250 capsules [Up to 24 hour]
Changes in respiratory rate after using TQF3250 capsules [Up to 24 hour]
Changes in blood pressure after using TQF3250 capsules [Up to 24 hour]
Changes in blood oxygen saturation after using TQF3250 capsules [Up to 24 hour]

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