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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04593511




Registration number
NCT04593511
Ethics application status
Date submitted
21/09/2020
Date registered
20/10/2020

Titles & IDs
Public title
to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
LY03009/CT-AUS-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY03009 F1
Treatment: Drugs - LY03009 F2
Treatment: Drugs - LY03009 F3
Treatment: Drugs - LY03009 F4

Experimental: Formulation 1 - a single dose of LY03009 F1

Experimental: Formulation 2 - a single dose of LY03009 F2

Experimental: Formulation 3 - a single dose of LY03009 F3

Experimental: Formulation 4 - a single dose of LY03009 F4


Treatment: Drugs: LY03009 F1
a single dose of LY03009 F1

Treatment: Drugs: LY03009 F2
a single dose of LY03009 F2

Treatment: Drugs: LY03009 F3
a single dose of LY03009 F3

Treatment: Drugs: LY03009 F4
a single dose of LY03009 F4
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of adverse events
Timepoint [1] 0 0
From screening up to day 98
Primary outcome [2] 0 0
Frequency of adverse events
Timepoint [2] 0 0
From screening up to day 161
Secondary outcome [1] 0 0
Maximum (peak) plasma concentration (Cmax) of LY03009
Timepoint [1] 0 0
From screening up to day 98
Secondary outcome [2] 0 0
Maximum (peak) plasma concentration (Cmax) of LY03009
Timepoint [2] 0 0
From screening up to day 161
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
Timepoint [3] 0 0
From screening up to day 98
Secondary outcome [4] 0 0
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009
Timepoint [4] 0 0
From screening up to day 161
Secondary outcome [5] 0 0
Area under the plasma concentration-time curve from time zero to infinity (AUC0-8) of LY03009
Timepoint [5] 0 0
From screening up to day 98
Secondary outcome [6] 0 0
Area under the plasma concentration-time curve from time zero to infinity (AUC0-8) of LY03009
Timepoint [6] 0 0
From screening up to day 161
Secondary outcome [7] 0 0
Time to maximum plasma concentration (Tmax) of LY03009
Timepoint [7] 0 0
From screening up to day 98
Secondary outcome [8] 0 0
Time to maximum plasma concentration (Tmax) of LY03009
Timepoint [8] 0 0
From screening up to day 161
Secondary outcome [9] 0 0
Terminal elimination half-life (t1/2) of LY03009
Timepoint [9] 0 0
From screening up to day 98
Secondary outcome [10] 0 0
Terminal elimination half-life (t1/2) of LY03009
Timepoint [10] 0 0
From screening up to day 161
Secondary outcome [11] 0 0
Apparent clearance (CL/F) of LY03009
Timepoint [11] 0 0
From screening up to day 98
Secondary outcome [12] 0 0
Apparent clearance (CL/F) of LY03009
Timepoint [12] 0 0
From screening up to day 161
Secondary outcome [13] 0 0
Apparent volume of distribution (Vz/F) of LY03009
Timepoint [13] 0 0
From screening up to day 98
Secondary outcome [14] 0 0
Apparent volume of distribution (Vz/F) of LY03009
Timepoint [14] 0 0
From screening up to day 161
Secondary outcome [15] 0 0
Terminal elimination rate constant (?z) of LY03009
Timepoint [15] 0 0
From screening up to day 98
Secondary outcome [16] 0 0
Terminal elimination rate constant (?z) of LY03009
Timepoint [16] 0 0
From screening up to day 161
Secondary outcome [17] 0 0
Mean residence time (MRT) of LY03009
Timepoint [17] 0 0
From screening up to day 98
Secondary outcome [18] 0 0
Mean residence time (MRT) of LY03009
Timepoint [18] 0 0
From screening up to day 161
Secondary outcome [19] 0 0
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
Timepoint [19] 0 0
From screening up to day 98
Secondary outcome [20] 0 0
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009
Timepoint [20] 0 0
From screening up to day 161

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Luye Pharma Group Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Angela Molga
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04593511