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A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LY03003
Sponsored by
Luye Pharma Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring LY03003

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    7mg dose group

    14mg dose group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Plasma drug concentration
    Cmax

    Secondary Outcome Measures

    Vital signs
    Blood pressure
    Vital signs
    Weight

    Full Information

    First Posted
    November 5, 2020
    Last Updated
    November 11, 2020
    Sponsor
    Luye Pharma Group Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04627155
    Brief Title
    A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 15, 2013 (Actual)
    Primary Completion Date
    May 20, 2013 (Actual)
    Study Completion Date
    May 20, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Luye Pharma Group Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    LY03003

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    7mg dose group
    Arm Type
    Experimental
    Arm Title
    14mg dose group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    LY03003
    Intervention Description
    Rotigotine,extended-release microspheres
    Primary Outcome Measure Information:
    Title
    Plasma drug concentration
    Description
    Cmax
    Time Frame
    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 Outcome Measure Information:
    Title
    Vital signs
    Description
    Blood pressure
    Time Frame
    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
    Title
    Vital signs
    Description
    Weight
    Time Frame
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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; 13. Researchers believe that the participants are not suitable.

    12. IPD Sharing Statement

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    A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

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