None listed
Conditions
Brief summary
This study will assess safety and pharmacokinetics of inhaled (nebulised) TLB001 which is being developed as a potential treatment for idiopathic pulmonary fibrosis. It will be run as a single ascending dose (Part A) and multiple ascending dose (Part B) study. Participants will be residential in the unit for 3 (Part A) or 16 (Part B) nights, and also attend final study outpatient visits.
Interventions
TLB001 is a liquid for inhalation via a nebuliser.
Part A: Single dose inhaled TLB001 administered on Day 1.
Planned doses (to be confirmed based on accruing safety data) for Cohorts 1 - 4 are 0.1, 0.2, 0.6 and 1.2 milligrams respectively. Cohort 5 dose to be confirmed and may be higher or lower than 1.2 milligrams
Part B: Inhaled TLB001 administered once a day for 14 days (Day 1 to Day 14 inclusive).
3 cohorts planned; doses to be confirmed based on Part A data
Each cohort has 8 participan
TLB001 is a liquid for inhalation via a nebuliser. Part A: Single dose inhaled TLB001 administered on Day 1. Planned doses (to be confirmed based on accruing safety data) for Cohorts 1 - 4 are 0.1, 0.2, 0.6 and 1.2 milligrams respectively. Cohort 5 dose to be confirmed and may be higher or lower than 1.2 milligrams Part B: Inhaled TLB001 administered once a day for 14 days (Day 1 to Day 14 inclusive). 3 cohorts planned; doses to be confirmed based on Part A data Each cohort has 8 participants; 6 will receive TLB001 Each participant will be included in one cohort only. All doses will be administered by site staff.
Sponsors
Tianli Biotech Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
-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
Exclusion criteria
- 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.
Outcome results
None listed