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

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ClinicalTrials.gov Identifier: NCT04108234
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 26, 2019
First Posted Date  ICMJE September 30, 2019
Last Update Posted Date April 29, 2021
Actual Study Start Date  ICMJE October 24, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2019)
Incidence of Adverse Events (Safety and Tolerability) [ Time Frame: Pre-dose to Day8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
Incidence of Adverse Events [Safety and Tolerability]) [ Time Frame: Pre-dose to Day8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2019)
  • Assessment of PK parameter-Area under drug-time curve (AUC) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-peak time (Tmax) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-peak concentration (Cmax) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-half-life (t1/2) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-apparent clearance rate (CL/F) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-apparent distribution volume (Vz/F) [ Time Frame: Pre-dose to Day2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • Assessment of PK parameter-Area under drug-time curve (AUC0-t) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-Area under drug-time curve (AUC0-∝) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-peak time (Tmax) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-peak concentration (Cmax) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-half-life (t1/2) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-pparent clearance rate (CL/F) [ Time Frame: Pre-dose to Day2 ]
  • Assessment of PK parameter-apparent distribution volume (Vz/F) [ Time Frame: Pre-dose to Day2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of HR071603(Ketamine Nasal Spray) in Healthy Subjects
Official Title  ICMJE Safety, Tolerance and Pharmacokinetics of Hydrochloric Acid (R) -Ketamine Nasal Spray in Healthy Subjects: A Randomized, Double Blind, Placebo-Controlled Phase I Clinical Trial
Brief Summary The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
HR071603 monotherapy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: HR071603
    HR071603 monotherapy ,nasal spray
    Other Name: R-ketamine
  • Drug: placebo
    placebo,nasal spray
Study Arms  ICMJE
  • Experimental: Treatment group A
    HR071603,nasal spray,dose escalation.
    Intervention: Drug: HR071603
  • Placebo Comparator: Treatment group B
    Placebo, nasal spray
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jianjun Zou 021-68868570 zoujianjun@hrglobe.cn
Contact: xiaoli cai 02161623506 caixiaoli@hrglobe.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04108234
Other Study ID Numbers  ICMJE HR071603-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP