A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

NCT04627155 | Completed Phase 1

• 1 other identifier: LY03003/CT-CHN-101
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Parkinson Disease

Keywords

LY03003

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

7mg dose group

EXPERIMENTAL

Drug: LY03003

14mg dose group

EXPERIMENTAL

Drug: LY03003

Interventions

LY03003 DRUG

Rotigotine,extended-release microspheres

14mg dose group; 7mg dose group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• \. Researchers believe that the participants are not suitable.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 13, 2020
• Study Start: March 15, 2013
• Primary Completion: May 20, 2013
• Study Completion: May 20, 2013
• Last Updated: November 13, 2020

Record last verified: 2020-11