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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: TLC19 Vehicle; Drug: TLC19

• Registration Number: NCT04697654
• Lead Sponsor: Taiwan Liposome Company

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.

Detailed 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.

Study Timeline

• Study Start: 2020-10-08
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
TLC19 Vehicle (high dose)	TLC19 Vehicle	TLC19 Vehicle 6ml single dose
TLC19 (low dose)	TLC19	TLC19 2ml single dose
TLC19 Vehicle (medium dose)	TLC19 Vehicle	TLC19 Vehicle 4ml single dose
TLC19 Vehicle (low dose)	TLC19 Vehicle	TLC19 Vehicle 2ml single dose
TLC19 (medium dose)	TLC19	TLC19 4ml single dose
TLC19 (high dose)	TLC19	TLC19 6ml single dose

Primary Outcome Measures

Name	Time	Method
Incidence of AEs	0-28 Days	To evaluate the severity, seriousness, outcome, and action taken of AE

Secondary Outcome Measures

Name	Time	Method
Time to reach maximum blood concentration	0-168 hours	Tmax
Area under the blood concentration-time curve	0-168 hours	AUC0-last
Maximum blood concentration	0-168 hours	Cmax

Trial Locations

Locations (1)

Mackay Memorial Hospital Tamsui Branch; 🇨🇳 Taipei, Taiwan