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

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ClinicalTrials.gov Identifier: NCT04593511
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2020
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: LY03009 F1 Drug: LY03009 F2 Drug: LY03009 F3 Drug: LY03009 F4 Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Formulation 1
a single dose of LY03009 F1
 Drug: LY03009 F1
a single dose of LY03009 F1
Experimental: Formulation 2
a single dose of LY03009 F2
 Drug: LY03009 F2
a single dose of LY03009 F2
Experimental: Formulation 3
a single dose of LY03009 F3
 Drug: LY03009 F3
a single dose of LY03009 F3
Experimental: Formulation 4
a single dose of LY03009 F4
 Drug: LY03009 F4
a single dose of LY03009 F4


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Frequency of adverse events [ Time Frame: From screening up to day 161 ]
    Frequency of adverse events. Apply to cohort F4.


Secondary Outcome Measures :
  1. Maximum (peak) plasma concentration (Cmax) of LY03009 [ Time Frame: From screening up to day 98 ]
    Maximum (peak) plasma concentration (Cmax) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.

  2. Maximum (peak) plasma concentration (Cmax) of LY03009 [ Time Frame: From screening up to day 161 ]
    Maximum (peak) plasma concentration (Cmax) of LY03009. Apply to cohort F4

  3. 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.Apply to cohort F1, cohort F2 and cohort F3.

  4. 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 the last measurable concentration (AUC0-t) of LY03009.Apply to cohort F4

  5. 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.Apply to cohort F1, cohort F2 and cohort F3.

  6. Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) 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. Apply to cohort F4

  7. Time to maximum plasma concentration (Tmax) of LY03009 [ Time Frame: From screening up to day 98 ]
    Time to maximum plasma concentration (Tmax) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.

  8. Time to maximum plasma concentration (Tmax) of LY03009 [ Time Frame: From screening up to day 161 ]
    Time to maximum plasma concentration (Tmax) of LY03009. Apply to cohort F4

  9. Terminal elimination half-life (t1/2) of LY03009 [ Time Frame: From screening up to day 98 ]
    Terminal elimination half-life (t1/2) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.

  10. Terminal elimination half-life (t1/2) of LY03009 [ Time Frame: From screening up to day 161 ]
    Terminal elimination half-life (t1/2) of LY03009.Apply to cohort F4

  11. Apparent clearance (CL/F) of LY03009 [ Time Frame: From screening up to day 98 ]
    Apparent clearance (CL/F) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.

  12. Apparent clearance (CL/F) of LY03009 [ Time Frame: From screening up to day 161 ]
    Apparent clearance (CL/F) of LY03009. Apply to cohort F4

  13. Apparent volume of distribution (Vz/F) of LY03009 [ Time Frame: From screening up to day 98 ]
    Apparent volume of distribution (Vz/F) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.

  14. Apparent volume of distribution (Vz/F) of LY03009 [ Time Frame: From screening up to day 161 ]
    Apparent volume of distribution (Vz/F) of LY03009. Apply to cohort F4

  15. Terminal elimination rate constant (λz) of LY03009 [ Time Frame: From screening up to day 98 ]
    Terminal elimination rate constant (λz) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.

  16. Terminal elimination rate constant (λz) of LY03009 [ Time Frame: From screening up to day 161 ]
    Terminal elimination rate constant (λz) of LY03009. Apply to cohort F4

  17. Mean residence time (MRT) of LY03009 [ Time Frame: From screening up to day 98 ]
    Mean residence time (MRT) of LY03009. Apply to cohort F1, cohort F2 and cohort F3.

  18. Mean residence time (MRT) of LY03009 [ Time Frame: From screening up to day 161 ]
    Mean residence time (MRT) of LY03009. Apply to cohort F4

  19. 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. Apply to cohort F1, cohort F2 and cohort F3.

  20. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria：

To participate in the study, subjects must meet all of the following inclusion criteria:

  1. Willing and capable of giving signed written informed consent;
  2. Male or female, 18-65 years of age (inclusive) at screening;
  3. Body mass index (BMI, weight [kg]/height [m]2) between 18.0 and 30.0 kg/m2, inclusive;
  4. 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.
  5. 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.

Exclusion Criteria：

Subjects meeting any of the following criteria will be excluded from the study:

  1. 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;
  2. Hospital admission or major surgery within 3 months prior to screening, or plan to have surgery before the completion of study;
  3. 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;
  4. Unwillingness or inability to comply with food and beverage restrictions during study participation;
  5. Have a history of significant drug sensitivity or drug allergy, or known hypersensitivity to the study drugs, the metabolite or formulation excipients;
  6. Malignancy within 5 years of screening visit (excluding non-melanoma skin cancer and cervical carcinoma in situ that has been completely resected);
  7. Subject who is considered unsuitable for participating in the study in the opinion of investigator.
  8. Recent administration of live vaccine within 3 months prior to dosing and until at least 30 days after the completion of the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593511


Locations
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Australia, South Australia
CMAX clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Luye Pharma Group Ltd.
Investigators
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Principal Investigator: Angela Molga CMAX Clinical Research Pty Ltd
More Information
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Responsible Party: Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier: NCT04593511    
Other Study ID Numbers: LY03009/CT-AUS-101
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases