Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04697654




Registration number
NCT04697654
Ethics application status
Date submitted
4/01/2021
Date registered
6/01/2021
Date last updated
26/11/2021

Titles & IDs
Public title
The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
Scientific title
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
Secondary ID [1] 0 0
TLC19A1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TLC19
Treatment: Drugs - TLC19 Vehicle

Experimental: TLC19 (low dose) - TLC19 2ml single dose

Experimental: TLC19 (medium dose) - TLC19 4ml single dose

Experimental: TLC19 (high dose) - TLC19 6ml single dose

Sham Comparator: TLC19 Vehicle (low dose) - TLC19 Vehicle 2ml single dose

Sham Comparator: TLC19 Vehicle (medium dose) - TLC19 Vehicle 4ml single dose

Sham Comparator: TLC19 Vehicle (high dose) - TLC19 Vehicle 6ml single dose


Treatment: Drugs: TLC19
Hydroxychloroquine Liposome Inhalation Suspension

Treatment: Drugs: TLC19 Vehicle
Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of AEs
Timepoint [1] 0 0
0-28 Days
Secondary outcome [1] 0 0
Maximum blood concentration
Timepoint [1] 0 0
0-168 hours
Secondary outcome [2] 0 0
Time to reach maximum blood concentration
Timepoint [2] 0 0
0-168 hours
Secondary outcome [3] 0 0
Area under the blood concentration-time curve
Timepoint [3] 0 0
0-168 hours

Eligibility
Key inclusion criteria
1. Male or female 18 to 65 years of age

2. Body mass index (BMI) 18.0 to 30.0 kg/m2.

3. Never-smoker
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Body weight <50 kg

2. Donation of blood (450 mL) or blood loss within 3 months prior to study

3. Contraindication, allergy, or hypersensitivity to hydroxychloroquine or chloroquine or
other 4 aminoquinolines

4. Use of any prescription or OTC medications or herbal supplements within 2 weeks (or
5half-lives if longer) prior to study

5. Use of any investigational product/medical device within 30 days or 5 half-lives prior
to study, or participation in =4 investigational drug studies within 1 year prior to
study

6. History or presence of any of the following conditions:

- Autoimmune or rheumatoid inflammatory disease

- Cardiac disorders

- Lung disease, prior intubation, or requiring use of an inhaler

- Liver cirrhosis or Child-Pugh class C

- Retinopathy or maculopathy

- Neuromuscular diseases

- Glucose-6 phosphate dehydrogenase deficiency

- Hematologic malignancy

- Chronic kidney disease or renal failure

- Psoriasis or porphyria

- Diabetes mellitus

- Severe allergic or anaphylactic reactions

- Any other significant condition that would preclude participation

7. History of substance abuse or dependency in the last 12 months, or a history of
recreational intravenous drug use over the last 5 years

8. Fever or symptomatic viral or bacterial infection within 2 weeks prior to study

9. Any clinically significant laboratory abnormality

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2021
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Taiwan
State/province [1] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Taiwan Liposome Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and
PK of single ascending doses of inhaled TLC19 in healthy volunteer subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04697654
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Carl Brown, PhD
Address 0 0
Taiwan Liposome Company, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04697654