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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
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
Secondary ID [1] 312241 0
TLB-TLB001-HV01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic pulmonary fibrosis 333948 0
Condition category
Condition code
Respiratory 330622 330622 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328692 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 338441 0
Safety of TLB001 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs)
Timepoint [1] 338441 0
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 [1] 435956 0
TLB001 levels in plasma
Timepoint [1] 435956 0
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

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/07/2024
Actual
8/08/2024
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
28/03/2025
Actual
Sample size
Target
64
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26642 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 42682 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 316619 0
Commercial sector/Industry
Name [1] 316619 0
Tianli Biotech Pty Ltd
Country [1] 316619 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tianli Biotech Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 318805 0
None
Name [1] 318805 0
None
Address [1] 318805 0
Country [1] 318805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315404 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315404 0
Ethics committee country [1] 315404 0
Australia
Date submitted for ethics approval [1] 315404 0
27/05/2024
Approval date [1] 315404 0
04/06/2024
Ethics approval number [1] 315404 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134598 0
Dr Sam Francis
Address 134598 0
Nucleus Network, 89 Commercial Road, Melbourne, VIC 3004
Country 134598 0
Australia
Phone 134598 0
+61 3 8593 9801
Fax 134598 0
Email 134598 0
s.francis@nucleusnetwork.com.au
Contact person for public queries
Name 134599 0
Sam Francis
Address 134599 0
Nucleus Network, 89 Commercial Road, Melbourne, VIC 3004
Country 134599 0
Australia
Phone 134599 0
+61 3 8593 9800
Fax 134599 0
Email 134599 0
s.francis@nucleusnetwork.com.au
Contact person for scientific queries
Name 134600 0
Alistair Stewart
Address 134600 0
c/- Tianli Biotech Pty Ltd, Level 2, 115 – 119 Collins St Melbourne VIC 3000
Country 134600 0
Australia
Phone 134600 0
+61 431 270 122
Fax 134600 0
Email 134600 0
astew@unimelb.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.