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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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: Devices - LungFit

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


Treatment: Devices: LungFit
LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

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)

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/study/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/study/NCT04697654