A Study of TQC3927 Powder for Inhalation in Healthy Adult Subjects - Trial NCT06408285
Access comprehensive clinical trial information for NCT06408285 through Pure Global AI's free database. This Phase 1 trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and is currently Not yet recruiting. The study focuses on Chronic Obstructive Pulmonary Disease. Target enrollment is 60 participants.
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Study Focus
Sponsor & Location
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Timeline & Enrollment
Phase 1
May 01, 2024
Feb 01, 2025
Primary Outcome
Adverse events (AE),Serious adverse events (SAE),Abnormal security check,Pharmacokinetics:Peak concentration (Cmax),Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t]),Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]),Time to reach maximum (peak) plasma concentration following drug administration (Tmax),Half-life (t1/2),Apparent volume of distribution(Vd/F),Apparent clearance (CLz/F),End elimination rate (ฮปz),Residual area percentage of the TQC3927 (AUC_%Extrap),Mean residence time from zero to last measurable concentration (MRT0-t),Mean residence time from zero to infinity (MRT0-โ),Accumulated excretion of drugs in urine and feces (Aecum),Accumulated excretion of drugs in urine (Aeu,cum),Accumulated excretion of drugs in feces(Aef,cum),Renal clearance (CLr),Total drug excretion ratio in urine and feces (Fe%),Drug excretion ratio in urine (Fe%u),Drug excretion ratio in feces (Fe%f)
Summary
This is a dose escalation trial. The dosing regimen involves a single-dose study. This is a
 single-center, randomized, double-blind, placebo-controlled study to evaluate the safety,
 tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in healthy
 adults subjects.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06408285
Non-Device Trial