Clinical trial NCT04593511: to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of adverse events
timeFrame: From screening up to day 98
measure: Frequency of adverse events
timeFrame: From screening up to day 161
Secondary outcomes:
measure: Maximum (peak) plasma concentration (Cmax) of LY03009
timeFrame: From screening up to day 98
measure: Maximum (peak) plasma concentration (Cmax) of LY03009
timeFrame: From screening up to day 161
measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
timeFrame: From screening up to day 98
measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
timeFrame: From screening up to day 161
measure: Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009
timeFrame: From screening up to day 98
measure: Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009
timeFrame: From screening up to day 161
measure: Time to maximum plasma concentration (Tmax) of LY03009
timeFrame: From screening up to day 98
measure: Time to maximum plasma concentration (Tmax) of LY03009
timeFrame: From screening up to day 161
measure: Terminal elimination half-life (t1/2) of LY03009
timeFrame: From screening up to day 98
measure: Terminal elimination half-life (t1/2) of LY03009
timeFrame: From screening up to day 161
measure: Apparent clearance (CL/F) of LY03009
timeFrame: From screening up to day 98
measure: Apparent clearance (CL/F) of LY03009
timeFrame: From screening up to day 161
measure: Apparent volume of distribution (Vz/F) of LY03009
timeFrame: From screening up to day 98
measure: Apparent volume of distribution (Vz/F) of LY03009
timeFrame: From screening up to day 161
measure: Terminal elimination rate constant (λz) of LY03009
timeFrame: From screening up to day 98
measure: Terminal elimination rate constant (λz) of LY03009
timeFrame: From screening up to day 161
measure: Mean residence time (MRT) of LY03009
timeFrame: From screening up to day 98
measure: Mean residence time (MRT) of LY03009
timeFrame: From screening up to day 161
measure: Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
timeFrame: From screening up to day 98
measure: Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
timeFrame: From screening up to day 161
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX clinical Research Pty Ltd
state: South Australia
Study officials:
affiliation: CMAX Clinical Research Pty Ltd
name: Angela Molga
role: PRINCIPAL_INVESTIGATOR
References: