DBM-1152A Inhalation Solution in Chinese Healthy Subjects (NCT07447141) | Clinical Trial Compass
CompletedPhase 1
DBM-1152A Inhalation Solution in Chinese Healthy Subjects
China44 participantsStarted 2023-12-24
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Timeframe: From informed consent up to Day 4 (End of study).
Trial details
NCT IDNCT07447141
SponsorJoincare Pharmaceutical Group Industry Co., Ltd
. 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.