Clinical TrialHealthy VolunteersKetaminePlaceboCompleted

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

The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 (ketamine nasal spray) in healthy subjects.

Target Enrollment
50 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, parallel-group Phase I study in healthy male volunteers (n=50) comparing HR071603 (R-ketamine) nasal spray versus placebo with dose-escalation cohorts to evaluate safety and pharmacokinetics.

Primary assessments include adverse events, vital signs, ECG and clinical labs; pharmacokinetic sampling will characterise systemic exposure across dose cohorts.

Study Arms & Interventions

HR071603

experimental

HR071603 nasal spray; dose escalation per cohort.

Interventions

  • Ketamine
    via Other

    Nasal spray; R-ketamine (HR071603); dose escalation across cohorts.

Placebo

inactive

Placebo nasal spray

Interventions

  • Placebo
    via Other

    Placebo nasal spray comparator.

Participants

Ages
18 – 45
Sexes
male

Inclusion Criteria

  • 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

  • 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 on 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.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment50 participants
  • Timeline
    Start: 2019-10-24
    End: 2021-07-01
  • Compounds
    KetaminePlacebo
  • Topic
    Healthy Volunteers

Locations

Beijing AnDing hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China

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