A Study of HR071603(Ketamine Nasal Spray) in Healthy Subjects

Brief Summary

The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.

Intervention / Treatment

HR071603 monotherapy
  • HR071603 (DRUG)
    HR071603 monotherapy ,nasal spray
  • Placebo (DRUG)
    placebo,nasal spray

Condition or Disease

  • Depression


  • Phase 1
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 50 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment


    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Oct 24, 2019 ACTUAL
    Primary Completion: Jun 01, 2021 ACTUAL
    Completion Date: Jun 01, 2021 ACTUAL
    Study First Posted: Sep 30, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 15, 2022

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A


    Participant Groups

    • HR071603,nasal spray,dose escalation.

    • Placebo, nasal spray

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    1. Obtain informed consent prior to the start of any activity related to the trial, and have a thorough understanding of the purpose and meaning of the trial and be willing to comply with the protocol;
    2. Healthy males aged between 18 and 45 (including both ends);
    3. Weight ≥ 50kg, body mass index (BMI) in the range of 18.5 \~ 23.9 (including both ends);
    4. During the trial and within 30 days after the administration, willing to take contraceptive measures and ensure that no sperm is donated.

    Exclusion Criteria:

    1. A subject considered by the investigator to be unsuitable for nasal spray administration;
    2. Allergic to any component of the study drug;
    3. The underlying disease is not suitable for participation in the trial;
    4. 12-lead ECG results in the screening period are abnormal and clinically significant
    5. Liver dysfunction;
    6. Serum creatinine \> 1.2 × ULN during screening period;
    7. Screening for infectious diseases screening hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, human immunodeficiency virus (HIV) antibody test positive;
    8. Subject has been thoroughly examined, and the results are abnormal and clinically significant;
    9. Major operations were performed within 3 months before the screening period.
    10. Donate whole blood/plasma within one month before the screening period, or donate whole blood/plasma more than 400 ml within three months before the screening period;
    11. Positive urine drug test;
    12. The alcohol breath test is positive; or the average daily intake of alcohol exceeds 15g;
    13. Nicotine test is positive;
    14. History of drug abuse or alcohol abuse;
    15. In the past three months, over five cups of coffee or tea per day were consumed in an average;
    16. Any prescription drugs, over-the-counter drugs and health products were used within 2 weeks before screening.
    17. Participated in clinical trials of any drug or medical device within 3 months before screening ;
    18. Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.

    Primary Outcomes
    • Incidence of Adverse Events (Safety and Tolerability) Pre-dose to Day8
    Secondary Outcomes
    • Assessment of PK parameter-Area under drug-time curve (AUC) Pre-dose to Day2
    • Assessment of PK parameter-peak time (Tmax) Pre-dose to Day2
    • Assessment of PK parameter-peak concentration (Cmax) Pre-dose to Day2
    • Assessment of PK parameter-half-life (t1/2) Pre-dose to Day2
    • Assessment of PK parameter-apparent clearance rate (CL/F) Pre-dose to Day2
    • Assessment of PK parameter-apparent distribution volume (Vz/F) Pre-dose to Day2

    More Details

    NCT Number: NCT04108234
    Other IDs: HR071603-101
    Study URL: https://clinicaltrials.gov/study/NCT04108234
    Last updated: Sep 29, 2023