A Randomized, Double-blind, Single-center, Placebo-controlled, Dose-escalation Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of DBM-1152A Inhalation Solution in Chinese Healthy Subjects

Joincare Pharmaceutical Group Industry Co., Ltd1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2023年12月24日最近更新: 2026年3月3日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 44
试验地点: 1
主要终点: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A Inhalation Solution in healthy Chinese adult subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The 1 mg cohort is open-label. The 2 mg, 4 mg, 6 mg, and 9 mg cohorts are double-blind.

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Chinese healthy male or female subjects.
•Age 18 to 45 years (inclusive).
•Body weight: Male ≥50.0kg, Female≥45.0 kg; BMI within the range of 19.0 to 26.0 kg/m^2 (inclusive).
•Subjects (including their partners) are willing to use effective contraception from the screening period until 6 months after the last dose.
•Subjects must fully understand the study, participate voluntarily, and sign the written informed consent.

排除标准

•Clinically significant abnormalities in physical examination, chest X-ray, hematology, urinalysis, blood biochemistry, coagulation function, thyroid function, or ophthalmic examination during screening; or FEV1/FVC < 80% in pulmonary function tests.
•Positive results in virology screening (HBsAg, anti-HCV, anti-HIV, or TP-Ab).
•Abnormal vital signs at screening: Sitting systolic blood pressure < 90 mmHg or ≥ 140 mmHg, diastolic blood pressure < 55 mmHg or ≥ 90 mmHg; Pulse < 50 bpm or > 90 bpm; Body temperature < 35.9°C or > 37.6°C; Respiratory rate < 12 breaths/min or > 20 breaths/min.
•Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTc): Male ≥ 450 ms, Female ≥ 470 ms.
•Electrolyte or glucose abnormalities at screening: Hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia, or hyperglycemia.
•Current acute or chronic oral or pharyngeal diseases (e.g., oral ulcers, pharyngitis).
•History or presence of chronic or severe diseases in the endocrine, urinary, digestive, hematological, respiratory, cardiovascular, neuropsychiatric, or immune systems, or any other physiological condition that may interfere with the study results.
•History or presence of glaucoma, functional constipation, prostatic hyperplasia, urinary tract obstruction, urinary retention, epilepsy, hyperthyroidism, paradoxical bronchospasm, diabetes, or ketoacidosis.
•History or presence of Short QT Syndrome or Long QT Syndrome.
•Lower respiratory tract infection within 6 weeks prior to screening, or clinically significant upper respiratory tract disease within 2 weeks prior to screening.
•Surgery within 3 months prior to screening, especially procedures affecting drug absorption, distribution, metabolism, or excretion; or planned surgery during the study.
•Suspected allergy to DBM-1152A or its excipients; history of hypersensitivity to other anticholinergic drugs or β2-agonists; or history of significant food or drug allergies.
•History of drug abuse or drug dependence within 12 months prior to screening.
•Positive drug screening (morphine, methamphetamine, ketamine, MDMA, or THC) prior to enrollment.
•Excessive consumption of tea, coffee, or caffeinated beverages (≥8 cups/day, 250mL/cup) within the past 6 months; or consumption of caffeine-rich or grapefruit-rich food/beverages within 48 hours prior to screening.
•History of alcohol abuse within the past 12 months (Male ≥ 28 units/week, Female ≥ 21 units/week); or regular drinking (≥14 units/week) within 6 months prior to screening; or inability to abstain from alcohol during the study.
•Positive breath alcohol test (> 0 mg/100 mL) prior to enrollment.
•Current smoker or history of smoking.
•Positive nicotine test prior to enrollment.
•Use of any medications (including prescription, OTC, vitamins, herbal medicine, supplements, or vaccines) within 30 days prior to screening.
•Participation in any clinical trial of a drug or device within 3 months prior to screening.
•Blood donation or significant blood loss (> 400 mL) within 3 months prior to screening; or planned blood donation during or within 3 months after the study.
•Difficulty in venous blood collection or inability to tolerate venipuncture.
•History of needle syncope or blood syncope.
•Inability to tolerate inhalation administration.
•Strenuous exercise within 48 hours prior to screening.
•Pregnant or lactating women, or women planning pregnancy; use of long-acting estrogen/progestogen injections or implants within 6 months prior to screening; or positive pregnancy test.
•Male subjects (or their partners) or female subjects planning pregnancy, sperm donation, or egg donation within 6 months after the study, or unwilling to use contraception.
•Special dietary requirements or inability to comply with the standardized diet.
•Poor compliance.
•Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.

研究组 & 干预措施

1 mg DBM-1152A

Experimental

Participants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label)