Parkinson's DiseasePhase 1NCT04593511

to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers

A Phase 1 study testing LY03009 F1, LY03009 F2 and LY03009 F3 in people with Parkinson's Disease, run by Luye Pharma Group Ltd. at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson's Disease
What is being tested?: LY03009 F1, LY03009 F2 and LY03009 F3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteAustralia
Study dates: 2 Feb 2021to Oct 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

To participate in the study, subjects must meet all of the following inclusion criteria:
Willing and capable of giving signed written informed consent;
Male or female, 18-65 years of age (inclusive) at screening;
Body mass index (BMI, weight [kg]/height [m]2) between 18.0 and 30.0 kg/m2, inclusive;
The screening results within the normal range or outside the normal range but assessed as clinically non-significant by the Investigator based on detailed medical history, clinical laboratory tests, vital signs, physical examination, and 12-lead ECG; QTcF ≤450 msec for male subjects, and QTcF ≤470 msec for female subjects.
Males who are willing to remain abstinent; or if engaging in sexual intercourse with a female partner of childbearing potential, willing to use a condom in addition to having the female partner use a highly effective method of contraception throughout the study and until at least 3 months after the end of the study. This requirement does not apply to subjects in a same sex relationship or subjects with female partners of non-childbearing potential. Male subjects must also be willing to not donate sperm throughout the study and until at least 3 months after the end of the study.

Who cannot join

Subjects meeting any of the following criteria will be excluded from the study:
With history of history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, neurologic, bronchopulmonary, immunologic, and/or lipid metabolism disorders, and/or drug hypersensitivity, or any other condition that, in the opinion of the PI, would jeopardize the safety of the subject, affect the validity of the study results, or impair the ability to provide informed consent;
Hospital admission or major surgery within 3 months prior to screening, or plan to have surgery before the completion of study;
Receipt of another investigational product within 1 month or 5 half-lives of the other investigational product, whichever is longer, before study drug administration in this study;
Unwillingness or inability to comply with food and beverage restrictions during study participation;
Have a history of significant drug sensitivity or drug allergy, or known hypersensitivity to the study drugs, the metabolite or formulation excipients;

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Malignancy within 5 years of screening visit (excluding non-melanoma skin cancer and cervical carcinoma in situ that has been completely resected);
Subject who is considered unsuitable for participating in the study in the opinion of investigator.
Recent administration of live vaccine within 3 months prior to dosing and until at least 30 days after the completion of the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX clinical Research Pty Ltd
Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: An Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular Injection

The purpose of this study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers.

Read the detailed description

This is an open-label study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of four formulations of LY03009 (F1, F2, F3, F4) after a single intramuscular injection.

Approximately 40 healthy subjects are planned to be enrolled in this study and assigned to four cohorts (F1, F2, F3, F4) sequentially, 10 subjects per group at a fixed dose of 112 mg for F1~F3 and 224 mg for F4. Each subject will receive only one dose in this study.

Conditions: Parkinson's Disease
Being tested: LY03009 F1, LY03009 F2, LY03009 F3, LY03009 F4
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY03009 F1Drug
a single dose of LY03009 F1
LY03009 F2Drug
a single dose of LY03009 F2
LY03009 F3Drug
a single dose of LY03009 F3
LY03009 F4Drug
a single dose of LY03009 F4

Study groups in NCT04593511
Study group	Role	What they receive
Formulation 1	Experimental	a single dose of LY03009 F1 Receives: Drug: LY03009 F1
Formulation 2	Experimental	a single dose of LY03009 F2 Receives: Drug: LY03009 F2
Formulation 3	Experimental	a single dose of LY03009 F3 Receives: Drug: LY03009 F3
Formulation 4	Experimental	a single dose of LY03009 F4 Receives: Drug: LY03009 F4

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of adverse events
Frequency of adverse events. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Frequency of adverse events
Frequency of adverse events. Apply to cohort F4.
Measured: From screening up to day 161

Secondary outcomes (20)

Maximum (peak) plasma concentration (Cmax) of LY03009
Maximum (peak) plasma concentration (Cmax) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Maximum (peak) plasma concentration (Cmax) of LY03009
Maximum (peak) plasma concentration (Cmax) of LY03009. Apply to cohort F4
Measured: From screening up to day 161
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009.Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009.Apply to cohort F4
Measured: From screening up to day 161
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009.Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009. Apply to cohort F4
Measured: From screening up to day 161
Time to maximum plasma concentration (Tmax) of LY03009
Time to maximum plasma concentration (Tmax) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Time to maximum plasma concentration (Tmax) of LY03009
Time to maximum plasma concentration (Tmax) of LY03009. Apply to cohort F4
Measured: From screening up to day 161
Terminal elimination half-life (t1/2) of LY03009
Terminal elimination half-life (t1/2) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Terminal elimination half-life (t1/2) of LY03009
Terminal elimination half-life (t1/2) of LY03009.Apply to cohort F4
Measured: From screening up to day 161
Apparent clearance (CL/F) of LY03009
Apparent clearance (CL/F) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Apparent clearance (CL/F) of LY03009
Apparent clearance (CL/F) of LY03009. Apply to cohort F4
Measured: From screening up to day 161
Apparent volume of distribution (Vz/F) of LY03009
Apparent volume of distribution (Vz/F) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Apparent volume of distribution (Vz/F) of LY03009
Apparent volume of distribution (Vz/F) of LY03009. Apply to cohort F4
Measured: From screening up to day 161
Terminal elimination rate constant (λz) of LY03009
Terminal elimination rate constant (λz) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Terminal elimination rate constant (λz) of LY03009
Terminal elimination rate constant (λz) of LY03009. Apply to cohort F4
Measured: From screening up to day 161
Mean residence time (MRT) of LY03009
Mean residence time (MRT) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Mean residence time (MRT) of LY03009
Mean residence time (MRT) of LY03009. Apply to cohort F4
Measured: From screening up to day 161
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.
Measured: From screening up to day 98
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009. Apply to cohort F4
Measured: From screening up to day 161

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 2021Oct 2021

First posted20 Oct 2020
Study start2 Feb 2021
Primary completionOct 2021 (estimated)
Study completionOct 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
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: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04593511
Sponsor's protocol ID: LY03009/CT-AUS-101
Status last verified: Jun 2021
First submitted: 21 Sep 2020
Last updated: 8 Jun 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular Injection
ClinicalTrials.gov ID: NCT04593511
Acronym / sponsor ID: LY03009/CT-AUS-101
Conditions: Parkinson's Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
Study start: 2 Feb 2021 (actual)
Primary completion: Oct 2021 (estimated)
Study completion: Oct 2021 (estimated)
First posted: 20 Oct 2020 (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.

The purpose of this study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers.

Detailed description

This is an open-label study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of four formulations of LY03009 (F1, F2, F3, F4) after a single intramuscular injection.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Formulation 1	Experimental	Drug: LY03009 F1a single dose of LY03009 F1
Formulation 2	Experimental	Drug: LY03009 F2a single dose of LY03009 F2
Formulation 3	Experimental	Drug: LY03009 F3a single dose of LY03009 F3
Formulation 4	Experimental	Drug: LY03009 F4a single dose of LY03009 F4

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Willing and capable of giving signed written informed consent;
Male or female, 18-65 years of age (inclusive) at screening;
Body mass index (BMI, weight [kg]/height [m]2) between 18.0 and 30.0 kg/m2, inclusive;
The screening results within the normal range or outside the normal range but assessed as clinically non-significant by the Investigator based on detailed medical history, clinical laboratory tests, vital signs, physical examination, and 12-lead ECG; QTcF ≤450 msec for male subjects, and QTcF ≤470 msec for female subjects.
Males who are willing to remain abstinent; or if engaging in sexual intercourse with a female partner of childbearing potential, willing to use a condom in addition to having the female partner use a highly effective method of contraception throughout the study and until at least 3 months after the end of the study. This requirement does not apply to subjects in a same sex relationship or subjects with female partners of non-childbearing potential. Male subjects must also be willing to not donate sperm throughout the study and until at least 3 months after the end of the study.

Key exclusion criteria (9 listed)

With history of history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, neurologic, bronchopulmonary, immunologic, and/or lipid metabolism disorders, and/or drug hypersensitivity, or any other condition that, in the opinion of the PI, would jeopardize the safety of the subject, affect the validity of the study results, or impair the ability to provide informed consent;
Hospital admission or major surgery within 3 months prior to screening, or plan to have surgery before the completion of study;
Receipt of another investigational product within 1 month or 5 half-lives of the other investigational product, whichever is longer, before study drug administration in this study;
Unwillingness or inability to comply with food and beverage restrictions during study participation;
Have a history of significant drug sensitivity or drug allergy, or known hypersensitivity to the study drugs, the metabolite or formulation excipients;

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
LY03009 F1a single dose of LY03009 F1	Drug	Formulation 1
LY03009 F2a single dose of LY03009 F2	Drug	Formulation 2
LY03009 F3a single dose of LY03009 F3	Drug	Formulation 3
LY03009 F4a single dose of LY03009 F4	Drug	Formulation 4

Primary outcome

Frequency of adverse events
Time frame: From screening up to day 98
Frequency of adverse events. Apply to cohort F1, cohort F2 and cohort F3.
Frequency of adverse events
Time frame: From screening up to day 161
Frequency of adverse events. Apply to cohort F4.

20 secondary outcomes

Maximum (peak) plasma concentration (Cmax) of LY03009
Time frame: From screening up to day 98
Maximum (peak) plasma concentration (Cmax) of LY03009
Time frame: From screening up to day 161
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
Time frame: From screening up to day 98
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
Time frame: From screening up to day 161
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009
Time frame: From screening up to day 98
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009
Time frame: From screening up to day 161
Time to maximum plasma concentration (Tmax) of LY03009
Time frame: From screening up to day 98
Time to maximum plasma concentration (Tmax) of LY03009
Time frame: From screening up to day 161
Terminal elimination half-life (t1/2) of LY03009
Time frame: From screening up to day 98
Terminal elimination half-life (t1/2) of LY03009
Time frame: From screening up to day 161
Apparent clearance (CL/F) of LY03009
Time frame: From screening up to day 98
Apparent clearance (CL/F) of LY03009
Time frame: From screening up to day 161
Apparent volume of distribution (Vz/F) of LY03009
Time frame: From screening up to day 98
Apparent volume of distribution (Vz/F) of LY03009
Time frame: From screening up to day 161
Terminal elimination rate constant (λz) of LY03009
Time frame: From screening up to day 98
Terminal elimination rate constant (λz) of LY03009
Time frame: From screening up to day 161
Mean residence time (MRT) of LY03009
Time frame: From screening up to day 98
Mean residence time (MRT) of LY03009
Time frame: From screening up to day 161
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
Time frame: From screening up to day 98
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
Time frame: From screening up to day 161

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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.

Angela Molga principal investigator

CMAX Clinical Research Pty 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 LY03009 F1, LY03009 F2 and LY03009 F3 in people with Parkinson's Disease, run by Luye Pharma Group Ltd. at 1 site in Australia.

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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Jun 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 Australia. 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. 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?

Results are not available in the source record.

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?

Frequency of adverse events (time frame: From screening up to day 98). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04593511.

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 8 Jun 2021.