A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: LY03003

• Registration Number: NCT04627155
• Lead Sponsor: Luye Pharma Group Ltd.

Brief Summary

This study is to evaluate the human tolerance and pharmacokinetics of LY03003.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-15
• Primary Completion: 2013-05-20
• Study Completion: 2013-05-20
• Status Verified: 2020-11
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. aged 18 to 45 years, no less than one-third of a single sex ratio;
2. 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);
3. body weight not less than 50 kg, body mass index between 19 and 24 kg/m2;
4. during 2 weeks not using any drugs;
5. no history of drug allergy or drug allergy;
6. voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form

Exclusion Criteria

1. abnormal health examination and clinical significance;

2. history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food;

3. Bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction;

4. history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness;

5. 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;

6. lactating women;

7. 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;

8. smokers, alcoholics and drug abusers;

9. drinkers within 24 hours before medication;

10. 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;

11. Researchers believe that the participants are not suitable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7mg dose group	LY03003	-
14mg dose group	LY03003	-

Primary Outcome Measures

Name	Time	Method
Plasma drug concentration	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	Cmax

Secondary Outcome Measures

Name	Time	Method
Vital signs	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	Weight