A Phase I, randomised, double blind, placebo-controlled, dose-escalating study of the safety, tolerability, and pharmacokinetics of single and repeat doses of TLB001 administered via inhalation to healthy volunteers

Tianli Biotech Pty Ltd0 个研究点目标入组 64 人开始时间: 2024年7月2日最近更新: 2024年9月9日

适应症

试验速览

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•Male or female aged from 18 to 50 years old inclusive.
•-Are in good general health without clinically significant medical history.
•-Weigh at least 50kg and have a body mass index (BMI) between 18 and 32kg/m2 inclusive

•- Pregnant or breast feeding.
•- Pulmonary function tests less than 80% predicted, at Screening or Day -1.
•- Asthma (other than childhood asthma that has resolved), COPD, or other respiratory diseases that may be exacerbated by, or prevent use of, a nebuliser.
•- Have a bleeding disorder or significant bruising or bleeding difficulties with blood draws.
•- Have any clinically significant abnormality at Screening or prior to dosing on Day 1 determined by medical history, vital signs, physical examination, blood chemistry, haematology, urinalysis, or a 12-lead electrocardiogram (ECG), as assessed by the investigator.
•- Smoke more than 2 cigarettes (or equivalent) per week and/or positive urine cotinine result at check in.
•- Have any other medical condition or significant co-morbidities, or any finding during Screening or prior to dosing on Day 1, which may interfere with the study objectives in the investigator’s opinion.

发起方

Tianli Biotech Pty Ltd