TQC3302 inhalation spray safety and pharmacokinetics in healthy adults

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China

This Phase 1 test gives healthy adults TQC3302 inhalation spray to see if it is safe, tolerable, and how the body absorbs and clears it.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07267130 on ClinicalTrials.gov

What this trial studies

This Phase 1, single-center, open-label study enrolls healthy adults aged 18–55 to characterize the safety, tolerability, and pharmacokinetics of single and repeated doses of TQC3302 inhalation spray. Most dose groups (Groups 1, 3, 4, 5, and 6) receive open-label administration, while Group 2 follows a randomized three-sequence, three-period crossover design to compare regimens. Several arms include co-administration with tiotropium/olodaterol and/or budesonide to observe combined-use effects, with serial blood sampling and safety monitoring to capture PK profiles and adverse events. Participants complete inhalation training, lung-function screening, and follow-up visits to document tolerability and drug levels.

Who should consider this trial

Good fit: Ideal candidates are healthy adults 18–55 with BMI 19–28 kg/m2, adequate lung function (FEV1 ≥80% predicted and FEV1/FVC ≥70%), able to complete inhalation training and agree to contraception requirements.

Not a fit: People with active pulmonary disease, current tuberculosis or bronchiectasis, or excluded conditions such as glaucoma, urinary tract obstruction, or benign prostatic hyperplasia are unlikely to benefit from participating.

Why it matters

Potential benefit: If results are favorable, this could support development of TQC3302 as a new inhaled treatment option for people with COPD.

How similar studies have performed: Established inhaled bronchodilators and corticosteroid combinations have proven benefit in COPD, but TQC3302 appears to be a novel compound undergoing early first-in-human/healthy-subject testing.

Eligibility criteria

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 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 (subjects and their partners)

Exclusion Criteria:

* 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
* 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

Where this trial is running

Beijing, Beijing Municipality

• China Japan Friendship Hospital Beijing — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jintong Li, Doctor

Conditions: Chronic Obstructive Pulmonary Disease