A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LY03003
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring LY03003
Eligibility Criteria
Inclusion Criteria:
- aged 18 to 45 years, no less than one-third of a single sex ratio;
- normal physical examination items (including general physical examination, blood and urine, blood biochemistry, anti-HBV, anti-HCV, anti-HIV, pregnancy test, ECG, chest X-ray);
- body weight not less than 50 kg, body mass index between 19 and 24 kg/m2;
- during 2 weeks not using any drugs;
- no history of drug allergy or drug allergy;
- voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form
Exclusion Criteria:
- abnormal health examination and clinical significance;
- history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food;
- Bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction;
- history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness;
- Women of childbearing age who have a positive pregnancy test or a negative pregnancy test but cannot ensure to take appropriate contraceptive measures during the study;
- lactating women;
- Male subjects who are unwilling to take appropriate contraceptive measures. Appropriate measures include the use of condoms, spermicides, or female partners using intrauterine devices (IUDs), ovarian caps, oral contraceptives, injected or subcutaneously implanted progestins, and tubal ligation surgery. Female partners must not be pregnant or lactating women;
- smokers, alcoholics and drug abusers;
- drinkers within 24 hours before medication;
- used any drugs within 2 weeks before the trial; Use of drugs with effect on liver and kidney function within 11.3 months; Participated in other drug trials within 12.3 months, donated blood loss (≥ 200ml), or sampled as subjects;
13. Researchers believe that the participants are not suitable.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
7mg dose group
14mg dose group
Arm Description
Outcomes
Primary Outcome Measures
Plasma drug concentration
Cmax
Secondary Outcome Measures
Vital signs
Blood pressure
Vital signs
Weight
Full Information
NCT ID
NCT04627155
First Posted
November 5, 2020
Last Updated
November 11, 2020
Sponsor
Luye Pharma Group Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04627155
Brief Title
A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2013 (Actual)
Primary Completion Date
May 20, 2013 (Actual)
Study Completion Date
May 20, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to evaluate the human tolerance and pharmacokinetics of LY03003.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
LY03003
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
7mg dose group
Arm Type
Experimental
Arm Title
14mg dose group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LY03003
Intervention Description
Rotigotine,extended-release microspheres
Primary Outcome Measure Information:
Title
Plasma drug concentration
Description
Cmax
Time Frame
Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection
Secondary Outcome Measure Information:
Title
Vital signs
Description
Blood pressure
Time Frame
Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection
Title
Vital signs
Description
Weight
Time Frame
Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 18 to 45 years, no less than one-third of a single sex ratio;
normal physical examination items (including general physical examination, blood and urine, blood biochemistry, anti-HBV, anti-HCV, anti-HIV, pregnancy test, ECG, chest X-ray);
body weight not less than 50 kg, body mass index between 19 and 24 kg/m2;
during 2 weeks not using any drugs;
no history of drug allergy or drug allergy;
voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form
Exclusion Criteria:
abnormal health examination and clinical significance;
history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food;
Bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction;
history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness;
Women of childbearing age who have a positive pregnancy test or a negative pregnancy test but cannot ensure to take appropriate contraceptive measures during the study;
lactating women;
Male subjects who are unwilling to take appropriate contraceptive measures. Appropriate measures include the use of condoms, spermicides, or female partners using intrauterine devices (IUDs), ovarian caps, oral contraceptives, injected or subcutaneously implanted progestins, and tubal ligation surgery. Female partners must not be pregnant or lactating women;
smokers, alcoholics and drug abusers;
drinkers within 24 hours before medication;
used any drugs within 2 weeks before the trial; Use of drugs with effect on liver and kidney function within 11.3 months; Participated in other drug trials within 12.3 months, donated blood loss (≥ 200ml), or sampled as subjects;
13. Researchers believe that the participants are not suitable.
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003
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