TQC3927 powder for inhalation
DrugTQC3927 is a targeted inhibitor
NCT Number: NCT06711991
This project is the stage of dose escalation, is was divided into single and multiple dose clinical study, This is a multi-center, randomized, double-blind, placebo-controlled , study to the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in Chronic Obstructive Pulmonary Disease
Looking for future studies?
Notify Me40 year–70 year
All sexes
Interventional
Phase 1
Aerospace Center Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TQC3927 is a targeted inhibitor
A placebo without drug substance.
Time frame: From the use of the investigational drug until the last study visit, up to day 16
The occurrence of all adverse events (AE) including abnormal laboratory test indicators.
Time frame: From the use of the investigational drug until the last study visit, up to day 16
The occurrence of all serious adverse events (SAE) .
Time frame: After administration of Day1 and Day7,before administration of Day3 and Day5
After administration of Day1 and Day7, the FEV1 trough value changed from baseline.
The changes in FEV1 before administration of Day3 and Day5 compared to baseline.
Time frame: After administration of Day1 and Day7,before administration of Day3 and Day5
FVC changes compared to baseline at each lung function visit point.
Time frame: After administration of Day1 and Day7,before administration of Day3 and Day5
After administration of Day1 and Day7, the peak FEV1 value changed from baseline.
Time frame: After administration of Day1 and Day7,before administration of Day3 and Day5
The area under the FEV1 curve of the average change from baseline after administration of D1 and D7 ranges from 0-6h (AUC0-6h), 0-12h (AUC0-12h), 12-24h (AUC12-24h), 0-24h (AUC0-24h), and FVC AUC (0-24h).
Time frame: After administration of Day1 and Day7,before administration of Day3 and Day5
The change in chronic obstructive pulmonary disease (CAT) score from baseline on the day after Day7 administration.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
The Cmax is the maximum observed plasma concentration of study drug.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Apparent volume of distribution of the TQC3927 in plasma
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Derived from semi logarithmic linear regression of eliminating phase concentration points.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Residual area percentage of the TQC3927 in plasma.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
The average residence time from 0:00 to the last measurable concentration time point.
Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Average residence time from 0:00 to infinity.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of Single/Multiple Dose Escalation of TQC3927 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05984823
Chronic Disease, Chronic Obstructive Pulmonary Disease
Leicester, Leicestershire, United Kingdom
View Trial DetailsNCT05572333
COPD, Chronic Disease
Frankfurt, Germany
View Trial DetailsNCT03641235
Chronic Disease, Chronic Obstructive Pulmonary Disease
Bordeaux, France
View Trial DetailsNCT05984680
Chronic Disease, Chronic Obstructive Pulmonary Disease
Winston-Salem, North Carolina, United States
View Trial Details