NCT04697654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

November 26, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

January 4, 2021

Last Update Submit

November 24, 2021

Conditions

COVID-19

Keywords

hydroxychloroquineInhalation

Outcome Measures

Primary Outcomes (1)

  • Incidence of AEs

    To evaluate the severity, seriousness, outcome, and action taken of AE

    0-28 Days

Secondary Outcomes (3)

  • Maximum blood concentration

    0-168 hours

  • Time to reach maximum blood concentration

    0-168 hours

  • Area under the blood concentration-time curve

    0-168 hours

Study Arms (6)

TLC19 (low dose)

EXPERIMENTAL

TLC19 2ml single dose

Drug: TLC19

TLC19 (medium dose)

EXPERIMENTAL

TLC19 4ml single dose

Drug: TLC19

TLC19 (high dose)

EXPERIMENTAL

TLC19 6ml single dose

Drug: TLC19

TLC19 Vehicle (low dose)

SHAM COMPARATOR

TLC19 Vehicle 2ml single dose

Drug: TLC19 Vehicle

TLC19 Vehicle (medium dose)

SHAM COMPARATOR

TLC19 Vehicle 4ml single dose

Drug: TLC19 Vehicle

TLC19 Vehicle (high dose)

SHAM COMPARATOR

TLC19 Vehicle 6ml single dose

Drug: TLC19 Vehicle

Interventions

TLC19DRUG

Hydroxychloroquine Liposome Inhalation Suspension

Also known as: TLC19 (Hydroxychloroquine Liposome Inhalation Suspension)
TLC19 (high dose)TLC19 (low dose)TLC19 (medium dose)
TLC19 VehicleDRUG

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

Also known as: TLC19 Vehicle (same formulation as TLC19 but without the active ingredient)
TLC19 Vehicle (high dose)TLC19 Vehicle (low dose)TLC19 Vehicle (medium dose)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 18 to 65 years of age
  • Body mass index (BMI) 18.0 to 30.0 kg/m2.
  • Never-smoker

You may not qualify if:

  • Body weight \<50 kg
  • Donation of blood (450 mL) or blood loss within 3 months prior to study
  • Contraindication, allergy, or hypersensitivity to hydroxychloroquine or chloroquine or other 4 aminoquinolines
  • Use of any prescription or OTC medications or herbal supplements within 2 weeks (or 5half-lives if longer) prior to study
  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital Tamsui Branch

Taipei, 10449, Taiwan

Location

MeSH Terms

Conditions

COVID-19Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carl Brown, PhD

    Taiwan Liposome Company, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

October 8, 2020

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

November 26, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)