A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

Parkinson Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627155
• Other study ID #: LY03003/CT-CHN-101
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2013
• Est. completion date: May 20, 2013

Study information

• Verified date: November 2020
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 20, 2013
• Est. primary completion date: May 20, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

13. Researchers believe that the participants are not suitable.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• LY03003
Rotigotine,extended-release microspheres

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma drug concentration	Cmax	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	Vital signs	Blood pressure	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	Vital signs	Weight	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