COVID-19Phase 1NCT04697654
The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
A Phase 1 study testing TLC19 in people with COVID-19, run by Taiwan Liposome Company at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- TLC19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Oct 2020to 18 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 to 65 years of age
- Body mass index (BMI) 18.0 to 30.0 kg/m2.
- Never-smoker
Who cannot join
- 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:
Show all 22Show fewer
- 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
- History of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years
- Fever or symptomatic viral or bacterial infection within 2 weeks prior to study
- Any clinically significant laboratory abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
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.
Read the 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
- Being tested
- TLC19, TLC19 Vehicle
- Keywords
- hydroxychloroquine, Inhalation
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC19Drug
Also called TLC19 (Hydroxychloroquine Liposome Inhalation Suspension)
Hydroxychloroquine Liposome Inhalation Suspension
TLC19 VehicleDrug
Also called TLC19 Vehicle (same formulation as TLC19 but without the active ingredient)
Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)
| Study group | Role | What they receive |
|---|---|---|
| TLC19 (low dose) | Experimental | TLC19 2ml single dose Receives: Drug: TLC19 |
| TLC19 (medium dose) | Experimental | TLC19 4ml single dose Receives: Drug: TLC19 |
| TLC19 (high dose) | Experimental | TLC19 6ml single dose Receives: Drug: TLC19 |
| TLC19 Vehicle (low dose) | Sham comparator | TLC19 Vehicle 2ml single dose Receives: Drug: TLC19 Vehicle |
| TLC19 Vehicle (medium dose) | Sham comparator | TLC19 Vehicle 4ml single dose Receives: Drug: TLC19 Vehicle |
| TLC19 Vehicle (high dose) | Sham comparator | TLC19 Vehicle 6ml single dose Receives: Drug: TLC19 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
To evaluate the severity, seriousness, outcome, and action taken of AE
Measured: 0-28 Days
Secondary outcomes (3)
Maximum blood concentration
Cmax
Measured: 0-168 hours
Time to reach maximum blood concentration
Tmax
Measured: 0-168 hours
Area under the blood concentration-time curve
AUC0-last
Measured: 0-168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start8 Oct 2020
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Brown, PhD, Study director, Taiwan Liposome Company, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697654
- Sponsor's protocol ID
- TLC19A1001
- Status last verified
- Sep 2021
- First submitted
- 4 Jan 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04697654
- Acronym / sponsor ID
- TLC19A1001
- Conditions
- COVID-19
- Keywords
- hydroxychloroquine, Inhalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TLC19 (low dose) | Experimental | Drug: TLC19TLC19 2ml single dose |
| TLC19 (medium dose) | Experimental | Drug: TLC19TLC19 4ml single dose |
| TLC19 (high dose) | Experimental | Drug: TLC19TLC19 6ml single dose |
| TLC19 Vehicle (low dose) | Sham comparator | Drug: TLC19 VehicleTLC19 Vehicle 2ml single dose |
| TLC19 Vehicle (medium dose) | Sham comparator | Drug: TLC19 VehicleTLC19 Vehicle 4ml single dose |
| TLC19 Vehicle (high dose) | Sham comparator | Drug: TLC19 VehicleTLC19 Vehicle 6ml single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 to 65 years of age
- Body mass index (BMI) 18.0 to 30.0 kg/m2.
- Never-smoker
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC19Also: TLC19 (Hydroxychloroquine Liposome Inhalation Suspension)Hydroxychloroquine Liposome Inhalation Suspension | Drug | TLC19 (high dose), TLC19 (low dose), TLC19 (medium dose) |
| TLC19 VehicleAlso: TLC19 Vehicle (same formulation as TLC19 but without the active ingredient)Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ) | Drug | TLC19 Vehicle (high dose), TLC19 Vehicle (low dose), TLC19 Vehicle (medium dose) |
Primary outcome
Incidence of AEs
Time frame: 0-28 Days
To evaluate the severity, seriousness, outcome, and action taken of AE
3 secondary outcomes
Maximum blood concentration
Time frame: 0-168 hours
Time to reach maximum blood concentration
Time frame: 0-168 hours
Area under the blood concentration-time curve
Time frame: 0-168 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown, PhD study director
Taiwan Liposome Company, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TLC19 in people with COVID-19, run by Taiwan Liposome Company at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: 0-28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.