TLB-001 safety and tolerability study

Phase 1

Recruiting

Conditions: Idiopathic pulmonary fibrosis
Respiratory - Other respiratory disorders / diseases

Registration Number: ACTRN12624000813583

Lead Sponsor: Tianli Biotech Pty Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 64

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of TLB001 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs) [There are no expected TEAEs at this stage of development.<br><br>TEAEs will be recorded and assessed by asking participants if they have experienced any and by direct observation during study visits. From first dose of study product on Day 1 to End of Study (EoS) on Day 8 (Part A) or Day 22 (Part B) post baseline]

Secondary Outcome Measures

Name	Time	Method
TLB001 levels in plasma[- Peak plasma concentration (Cmax) of TLB001 <br>- Time to peak plasma concentration (tmax) of TLB001 <br>- Area under the concentration-time curve of TLB001 from time 0 to infinity (extrapolated) (AUC0-inf) Part A: Collected pre dose and immediately post completion of dosing (time 0) and at 5, 15 and 30 minutes and 1, 2, 3, 4, 8, 12, and 24 hours post completion of dosing on Day 1<br>Part B: Collected pre dose and immediately post completion of dosing (time 0) and at 5, 15 and 30 minutes and 1, 2, 3, 4, 8, 12, and 24 hours post completion of dosing on Day 1 and Day 14]