NCT04697654

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	TLC19	Hydroxychloroquine Liposome Inhalation Suspension
DRUG	TLC19 Vehicle	Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2021-01-06
• Last updated: 2021-11-26

Locations

1 site across 1 country: Taiwan