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

NCT04593511 | Unknown Phase 1

• 1 other identifier: LY03009/CT-AUS-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Frequency of adverse events

  Frequency of adverse events. Apply to cohort F1, cohort F2 and cohort F3.

  From screening up to day 98

• Frequency of adverse events

  Frequency of adverse events. Apply to cohort F4.

  From screening up to day 161

Secondary Outcomes (20)

• Maximum (peak) plasma concentration (Cmax) of LY03009

  From screening up to day 98

• Maximum (peak) plasma concentration (Cmax) of LY03009

  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

  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

  From screening up to day 161

• Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009

  From screening up to day 98

Study Arms (4)

Formulation 1

EXPERIMENTAL

a single dose of LY03009 F1

Drug: LY03009 F1

Formulation 2

EXPERIMENTAL

a single dose of LY03009 F2

Drug: LY03009 F2

Formulation 3

EXPERIMENTAL

a single dose of LY03009 F3

Drug: LY03009 F3

Formulation 4

EXPERIMENTAL

a single dose of LY03009 F4

Drug: LY03009 F4

Interventions

LY03009 F1 DRUG

a single dose of LY03009 F1

Formulation 1

LY03009 F2 DRUG

a single dose of LY03009 F2

Formulation 2

LY03009 F3 DRUG

a single dose of LY03009 F3

Formulation 3

LY03009 F4 DRUG

a single dose of LY03009 F4

Formulation 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

CMAX clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Angela Molga

  CMAX Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 20, 2020
• Study Start: February 2, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)