A Study of TQC3927 Powder for Inhalation in Healthy Adult Subjects

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408285
• Other study ID #: TQC3927-I-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Lihong Liu, Doctor
• Phone: 13718936779
• Email: hongllh[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TQC3927 powder for inhalation
TQC3927 is a targeted inhibitor.
• TQC3927 powder for inhalation placebo
TQC3927 powder for inhalation placebo contains no active substance.

Locations

Country	Name	City	State
China	China Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	End elimination rate (?z)	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.
Primary	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
Primary	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.
Primary	Mean residence time from zero to infinity (MRT0-8)	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.