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

NCT04697654 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TLC19

Hydroxychloroquine Liposome Inhalation Suspension

DRUG

TLC19 Vehicle

Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)

Sponsors & Collaborators

  • Taiwan Liposome Company

    lead INDUSTRY

Principal Investigators

  • Carl Brown, PhD · Taiwan Liposome Company, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2021-06-18
Completion
2021-06-18

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697654 on ClinicalTrials.gov