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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: TQC3927 powder for inhalation; Drug: TQC3927 powder for inhalation placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • China Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content;
• Healthy subjects aged between 18 and 45 years (inclusive), both male and female;
• The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19~28 kg/m2;
• Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 90 days after the last dose (subjects and their partners).

Exclusion Criteria:

• Participated in any clinical trial within 3 months prior to the screening period;
• Past medical history or current cardiac, breath，endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
• Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc;
• People who have received or are planning to receive inactive or active vaccines during the 30 days prior to the screening period and the entire study period；
• Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases；
• Any history of drug allergies, Individuals with a specific history of allergies or allergies；
• Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products during the 3 months Before first administration, or those who cannot stop using any tobacco-based products during the trial；
• Regular alcohol consumption within the first 6 months of screening (women drink more than 14 standard units per week and men drink more than 21 standard units per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week during the 3 months prior to screening, or those who cannot refrain from alcohol during the trial, or those who tested positive for alcohol breath；
• History of drug or narcotics abuse or a positive result of urine drug test at screening；
• People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, chest radiograph and abdominal ultrasound during screening period；
• Those who have special dietary requirements and cannot follow a unified diet；
• Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP)；
• Pregnant or lactating women or those with positive blood pregnancy test results during the screening period；
• Subjects who are still unable to use TQC3927 inhalation powder correctly after training；
• Any situation in which the investigator believes that this poses a safety risk to the subject in the trial or may interfere with the conduct of the study, or that the investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQC3927 powder for inhalation; TQC3927 powder for inhalation is administered as a single dose	Drug: TQC3927 powder for inhalation; TQC3927 is a targeted inhibitor.
Placebo Comparator: TQC3927 powder for inhalation placebo; TQC3927 powder for inhalation placebo is administered as a single dose	Drug: TQC3927 powder for inhalation placebo; TQC3927 powder for inhalation placebo contains no active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AE)	The occurrence of all adverse events (AE).	From the use of the investigational drug until the last study visit, up to Day 9.
Serious adverse events (SAE)	The occurrence of all serious adverse events (SAE).	From the use of the investigational drug until the last study visit, up to Day 9.
Abnormal security check	The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.	From the use of the investigational drug until the last study visit, up to Day 9.
Pharmacokinetics:Peak concentration (Cmax)	The Cmax is the maximum observed plasma concentration of study drug.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])	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.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])	To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)	To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose
Half-life (t1/2)	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Apparent volume of distribution(Vd/F)	Apparent volume of distribution of the TQC3927 in plasma.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Apparent clearance (CLz/F)	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
End elimination rate (λz)	Derived from semi logarithmic linear regression of eliminating phase concentration points.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Residual area percentage of the TQC3927 (AUC_%Extrap)	Residual area percentage of the TQC3927 in plasma	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose
Mean residence time from zero to last measurable concentration (MRT0-t)	The average residence time from 0:00 to the last measurable concentration time point.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Mean residence time from zero to infinity (MRT0-∞)	Average residence time from 0:00 to infinity.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine and feces (Aecum)	Accumulated excretion of drugs in urine and feces from zero to time t.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine (Aeu,cum)	Accumulated excretion of drugs in urine from zero to time t.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in feces(Aef,cum)	Accumulated excretion of drugs in feces from zero to time t.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Renal clearance (CLr)	The ability of the kidneys to clear certain substances from plasma within 1 minute.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Total drug excretion ratio in urine and feces (Fe%)	The total excretion ratio of drugs in urine and feces from zero to time t.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Drug excretion ratio in urine (Fe%u)	The proportion of drug excretion in urine from zero to time t.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Drug excretion ratio in feces (Fe%f)	The proportion of drug excretion in feces from zero to time t.	Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Actual): August 19, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TQC3927-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No