The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers

COVID-19 Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697654
• Other study ID #: TLC19A1001
• Status: Completed
• Phase: Phase 1
• Start date: October 8, 2020
• Est. completion date: June 18, 2021

Study information

• Verified date: September 2021
• Source: Taiwan Liposome Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and PK of single ascending doses of inhaled TLC19 (Hydroxychloroquine Liposome Inhalation Suspension) in healthy volunteer subjects. Three dose levels will be assessed in sequential cohorts, with 2 mL, 4 mL, and 6 mL. Total of approximately 30 subjects will be randomized in the study in 3 cohorts. Subjects will be enrolled and randomized to receiving either TLC19 or TLC 19 Vehicle.

Drug Administration: Blinded study medication will be administered through inhalation via a portable vibration mesh nebulizer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• TLC19
Hydroxychloroquine Liposome Inhalation Suspension
• TLC19 Vehicle
Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital Tamsui Branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Liposome Company

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs	To evaluate the severity, seriousness, outcome, and action taken of AE	0-28 Days
Secondary	Maximum blood concentration	Cmax	0-168 hours
Secondary	Time to reach maximum blood concentration	Tmax	0-168 hours
Secondary	Area under the blood concentration-time curve	AUC0-last	0-168 hours