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Tests treatment safety and results for Chronic Obstructive Pulmonary Disease
Official title A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT07267130
What this study is testing
What is TQC3302 inhalation spray?
TQC3302 inhalation spray is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for chronic obstructive pulmonary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Groups 1, 3, 4, 5 and 6 of this research team adopted a single-center, open-label design. Group 2 used a three-sequence, three-period crossover design, where participants in this dose group were randomly assigned to the three sequences in a 1:1:1 ratio to undergo three-period crossover administration.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- people voluntarily joined the study, sign informed consent form before the study and fully understand the study content
- Healthy people aged between 18 and 55 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
- Inhalation administration training qualified.
- During the screening period, the percentage of predicted value for forced expiratory volume in one second (FEV1) before bronchodilator administration...
You likely can't join if
- Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc
- Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases
- 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...
- Any history of drug allergies, Individuals with a specific history of allergies or allergies
- Had undergone surgery within 1 month prior to screening period or expected to undergo surgery during the study period
- People with special dietary requirements who cannot follow a standard diet;
See the full eligibility criteria
- people voluntarily joined the study, sign informed consent form before the study and fully understand the study content
- Healthy people aged between 18 and 55 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
- Inhalation administration training qualified.
- During the screening period, the percentage of predicted value for forced expiratory volume in one second (FEV1) before bronchodilator administration is ≥80%, and FEV1/forced vital capacity (FVC) is ≥70%.
- Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 90 days after the last dose (people and their partners)
- Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc
- Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases
- 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
- Any history of drug allergies, Individuals with a specific history of allergies or allergies
- Had undergone surgery within 1 month prior to screening period or expected to undergo surgery during the study period
- People with special dietary requirements who cannot follow a standard diet;
- People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness；
- 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.