Pure Global AI
NCT06408285Not yet recruiting

A Study of TQC3927 Powder for Inhalation in Healthy Adult Subjects

A Phase I Clinical Study on the Safety, Tolerance and Pharmacokinetic Characteristics of Single Dose Escalation of TQC3927 Powder for Inhalation in Healthy Adult Subjects
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Phase 1ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
TQC3927 powder for inhalation
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
May 01, 2024
End date
Feb 01, 2025
Enrollment
60 participants
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 (λz),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-∞),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
Other chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease, unspecifiedOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06408285
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.