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A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

Sponsor
Luye Pharma Group Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04627155
Collaborator
(none)
20
Enrollment
2
Arms
2.2
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection
Actual Study Start Date :
Mar 15, 2013
Actual Primary Completion Date :
May 20, 2013
Actual Study Completion Date :
May 20, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 7mg dose group

Drug: LY03003
Rotigotine,extended-release microspheres
Experimental: 14mg dose group

Drug: LY03003
Rotigotine,extended-release microspheres

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  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]

    Weight

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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;

  11. Researchers believe that the participants are not suitable.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Luye Pharma Group Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier:
NCT04627155
Other Study ID Numbers:
  • LY03003/CT-CHN-101
First Posted:
Nov 13, 2020
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luye Pharma Group Ltd.
LY03003
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Nov 13, 2020