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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04108234
Recruitment Status : Completed
First Posted : September 30, 2019
Last Update Posted : June 16, 2022
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Depression Drug: HR071603 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: HR071603 monotherapy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety, Tolerance and Pharmacokinetics of Hydrochloric Acid (R) -Ketamine Nasal Spray in Healthy Subjects: A Randomized, Double Blind, Placebo-Controlled Phase I Clinical Trial
Actual Study Start Date : October 24, 2019
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Treatment group A
HR071603,nasal spray,dose escalation.
Drug: HR071603
HR071603 monotherapy ,nasal spray
Other Name: R-ketamine

Placebo Comparator: Treatment group B
Placebo, nasal spray
Drug: placebo
placebo,nasal spray

Primary Outcome Measures :
  1. Incidence of Adverse Events (Safety and Tolerability) [ Time Frame: Pre-dose to Day8 ]

Secondary Outcome Measures :
  1. Assessment of PK parameter-Area under drug-time curve (AUC) [ Time Frame: Pre-dose to Day2 ]
  2. Assessment of PK parameter-peak time (Tmax) [ Time Frame: Pre-dose to Day2 ]
  3. Assessment of PK parameter-peak concentration (Cmax) [ Time Frame: Pre-dose to Day2 ]
  4. Assessment of PK parameter-half-life (t1/2) [ Time Frame: Pre-dose to Day2 ]
  5. Assessment of PK parameter-apparent clearance rate (CL/F) [ Time Frame: Pre-dose to Day2 ]
  6. Assessment of PK parameter-apparent distribution volume (Vz/F) [ Time Frame: Pre-dose to Day2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108234

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China, Beijing
Beijing AnDing hospital affiliated to Capital Medical University
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04108234    
Other Study ID Numbers: HR071603-101
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavioral Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action