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Trial registered on ANZCTR
Registration number
ACTRN12624000813583
Ethics application status
Approved
Date submitted
5/06/2024
Date registered
2/07/2024
Date last updated
1/09/2024
Date data sharing statement initially provided
2/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
TLB-001 safety and tolerability study
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Scientific title
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
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Secondary ID [1]
312241
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TLB-TLB001-HV01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic pulmonary fibrosis
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Condition category
Condition code
Respiratory
330622
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
328692
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Treatment: Drugs
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Comparator / control treatment
Part A: Single dose inhaled placebo administered on Day 1.
5 cohorts planned
Part B: Inhaled placebo administered once a day for 14 days (Day 1 to Day 14 inclusive).
3 cohorts planned
Each cohort has 8 participants; 2 will receive placebo. Placebo is purified water.
Each participant will be included in one cohort only.
All doses will be administered by site staff.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Safety of TLB001 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs)
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Assessment method [1]
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There are no expected TEAEs at this stage of development.
TEAEs will be recorded and assessed by asking participants if they have experienced any and by direct observation during study visits.
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Timepoint [1]
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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
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Secondary outcome [1]
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TLB001 levels in plasma
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Assessment method [1]
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- Peak plasma concentration (Cmax) of TLB001
- Time to peak plasma concentration (tmax) of TLB001
- Area under the concentration-time curve of TLB001 from time 0 to infinity (extrapolated) (AUC0-inf)
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Timepoint [1]
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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
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
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
26/07/2024
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Actual
8/08/2024
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Date of last participant enrolment
Anticipated
31/01/2025
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Actual
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Date of last data collection
Anticipated
28/03/2025
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Actual
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Sample size
Target
64
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Accrual to date
20
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network - Melbourne
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Recruitment postcode(s) [1]
42682
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Tianli Biotech Pty Ltd
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Tianli Biotech Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
318805
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Country [1]
318805
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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27/05/2024
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Approval date [1]
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04/06/2024
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Ethics approval number [1]
315404
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sam Francis
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Address
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Nucleus Network, 89 Commercial Road, Melbourne, VIC 3004
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Country
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Australia
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Phone
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+61 3 8593 9801
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sam Francis
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Address
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Nucleus Network, 89 Commercial Road, Melbourne, VIC 3004
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Country
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Australia
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Phone
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+61 3 8593 9800
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Alistair Stewart
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Address
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c/- Tianli Biotech Pty Ltd, Level 2, 115 – 119 Collins St Melbourne VIC 3000
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Country
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Australia
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Phone
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+61 431 270 122
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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