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Completed

NCT Number: NCT06408285

A Study 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

China Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TQC3927 powder for inhalation

Drug

TQC3927 is a targeted inhibitor.

TQC3927 powder for inhalation placebo

Drug

TQC3927 powder for inhalation placebo contains no active substance.

Primary outcomes

  1. Adverse events (AE)

    Time frame: From the use of the investigational drug until the last study visit, up to Day 9.

    The occurrence of all adverse events (AE).

  2. Serious adverse events (SAE)

    Time frame: From the use of the investigational drug until the last study visit, up to Day 9.

    The occurrence of all serious adverse events (SAE).

  3. Abnormal security check

    Time frame: From the use of the investigational drug until the last study visit, up to Day 9.

    The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.

  4. Pharmacokinetics:Peak concentration (Cmax)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    The Cmax is the maximum observed plasma concentration of study drug.

  5. Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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.

  6. Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.

  7. Time to reach maximum (peak) plasma concentration following drug administration (Tmax)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose

    To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing

  8. Half-life (t1/2)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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.

  9. Apparent volume of distribution(Vd/F)

    Time frame: 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 of the TQC3927 in plasma.

  10. Apparent clearance (CLz/F)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

  11. End elimination rate (λz)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    Derived from semi logarithmic linear regression of eliminating phase concentration points.

  12. Residual area percentage of the TQC3927 (AUC_%Extrap)

    Time frame: 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 in plasma

  13. Mean residence time from zero to last measurable concentration (MRT0-t)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    The average residence time from 0:00 to the last measurable concentration time point.

  14. Mean residence time from zero to infinity (MRT0-∞)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    Average residence time from 0:00 to infinity.

  15. Accumulated excretion of drugs in urine and feces (Aecum)

    Time frame: 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 from zero to time t.

  16. Accumulated excretion of drugs in urine (Aeu,cum)

    Time frame: 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 from zero to time t.

  17. Accumulated excretion of drugs in feces(Aef,cum)

    Time frame: 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 from zero to time t.

  18. Renal clearance (CLr)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    The ability of the kidneys to clear certain substances from plasma within 1 minute.

  19. Total drug excretion ratio in urine and feces (Fe%)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    The total excretion ratio of drugs in urine and feces from zero to time t.

  20. Drug excretion ratio in urine (Fe%u)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    The proportion of drug excretion in urine from zero to time t.

  21. Drug excretion ratio in feces (Fe%f)

    Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.

    The proportion of drug excretion in feces from zero to time t.

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 10, 2024
Registry last updated
Oct 29, 2024

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.

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