A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04627155

Enrollment

Registered

2020-11-13

Start date

2013-03-15

Completion date

2013-05-20

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

LY03003

Brief summary

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

Interventions

DRUGLY03003

Rotigotine,extended-release microspheres

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	Blood pressure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026