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

NCT ID: NCT04697654

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-06-18

Brief Summary

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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

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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

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COVID-19

Keywords

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hydroxychloroquine Inhalation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TLC19 (low dose)

TLC19 2ml single dose

Group Type EXPERIMENTAL

TLC19

Intervention Type DRUG

Hydroxychloroquine Liposome Inhalation Suspension

TLC19 (medium dose)

TLC19 4ml single dose

Group Type EXPERIMENTAL

TLC19

Intervention Type DRUG

Hydroxychloroquine Liposome Inhalation Suspension

TLC19 (high dose)

TLC19 6ml single dose

Group Type EXPERIMENTAL

TLC19

Intervention Type DRUG

Hydroxychloroquine Liposome Inhalation Suspension

TLC19 Vehicle (low dose)

TLC19 Vehicle 2ml single dose

Group Type SHAM_COMPARATOR

TLC19 Vehicle

Intervention Type DRUG

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

TLC19 Vehicle (medium dose)

TLC19 Vehicle 4ml single dose

Group Type SHAM_COMPARATOR

TLC19 Vehicle

Intervention Type DRUG

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

TLC19 Vehicle (high dose)

TLC19 Vehicle 6ml single dose

Group Type SHAM_COMPARATOR

TLC19 Vehicle

Intervention Type DRUG

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

Interventions

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TLC19

Hydroxychloroquine Liposome Inhalation Suspension

Intervention Type DRUG

TLC19 Vehicle

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

Intervention Type DRUG

Other Intervention Names

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TLC19 (Hydroxychloroquine Liposome Inhalation Suspension) TLC19 Vehicle (same formulation as TLC19 but without the active ingredient)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taiwan Liposome Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Brown, PhD

Role: STUDY_DIRECTOR

Taiwan Liposome Company, Ltd.

Locations

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Mackay Memorial Hospital Tamsui Branch

Taipei, , Taiwan

Site Status

Countries

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Australia Taiwan

Other Identifiers

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TLC19A1001

Identifier Type: -

Identifier Source: org_study_id