search
Back to results

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

Primary Purpose

Depression

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HR071603
placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Beijing AnDing hospital affiliated to Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Arm Description

HR071603,nasal spray,dose escalation.

Placebo, nasal spray

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (Safety and Tolerability)

Secondary Outcome Measures

Assessment of PK parameter-Area under drug-time curve (AUC)
Assessment of PK parameter-peak time (Tmax)
Assessment of PK parameter-peak concentration (Cmax)
Assessment of PK parameter-half-life (t1/2)
Assessment of PK parameter-apparent clearance rate (CL/F)
Assessment of PK parameter-apparent distribution volume (Vz/F)

Full Information

First Posted
September 26, 2019
Last Updated
June 15, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04108234
Brief Title
A Study of HR071603(Ketamine Nasal Spray) in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
HR071603 monotherapy
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
HR071603,nasal spray,dose escalation.
Arm Title
Treatment group B
Arm Type
Placebo Comparator
Arm Description
Placebo, nasal spray
Intervention Type
Drug
Intervention Name(s)
HR071603
Other Intervention Name(s)
R-ketamine
Intervention Description
HR071603 monotherapy ,nasal spray
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo,nasal spray
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (Safety and Tolerability)
Time Frame
Pre-dose to Day8
Secondary Outcome Measure Information:
Title
Assessment of PK parameter-Area under drug-time curve (AUC)
Time Frame
Pre-dose to Day2
Title
Assessment of PK parameter-peak time (Tmax)
Time Frame
Pre-dose to Day2
Title
Assessment of PK parameter-peak concentration (Cmax)
Time Frame
Pre-dose to Day2
Title
Assessment of PK parameter-half-life (t1/2)
Time Frame
Pre-dose to Day2
Title
Assessment of PK parameter-apparent clearance rate (CL/F)
Time Frame
Pre-dose to Day2
Title
Assessment of PK parameter-apparent distribution volume (Vz/F)
Time Frame
Pre-dose to Day2

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; Healthy males aged between 18 and 45 (including both ends); Weight ≥ 50kg, body mass index (BMI) in the range of 18.5 ~ 23.9 (including both ends); During the trial and within 30 days after the administration, willing to take contraceptive measures and ensure that no sperm is donated. Exclusion Criteria: A subject considered by the investigator to be unsuitable for nasal spray administration; Allergic to any component of the study drug; The underlying disease is not suitable for participation in the trial; 12-lead ECG results in the screening period are abnormal and clinically significant Liver dysfunction; Serum creatinine > 1.2 × ULN during screening period; Screening for infectious diseases screening hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, human immunodeficiency virus (HIV) antibody test positive; Subject has been thoroughly examined, and the results are abnormal and clinically significant; Major operations were performed within 3 months before the screening period. 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; Positive urine drug test; The alcohol breath test is positive; or the average daily intake of alcohol exceeds 15g; Nicotine test is positive; History of drug abuse or alcohol abuse; In the past three months, over five cups of coffee or tea per day were consumed in an average; Any prescription drugs, over-the-counter drugs and health products were used within 2 weeks before screening. Participated in clinical trials of any drug or medical device within 3 months before screening ; 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.
Facility Information:
Facility Name
Beijing AnDing hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs