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CompletedNCT04108234Updated Jun 16, 2022

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

A Phase 1 interventional study of HR071603 and placebo in Depression, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 50 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Treatment group A

    HR071603,nasal spray,dose escalation.

    Drug: HR071603

  • Placebo comparator
    Treatment group B

    Placebo, nasal spray

    Drug: placebo

Interventions

  • DrugHR071603

    HR071603 monotherapy ,nasal spray

    Also known as: R-ketamine

  • Drugplacebo

    placebo,nasal spray

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events (Safety and Tolerability)

    Time frame: Pre-dose to Day8

Secondary outcomes

  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

07

Study locations

1 site
  • Beijing AnDing hospital affiliated to Capital Medical University
    Beijing, Beijing 100000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04108234
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 30, 2019
Start date
Oct 24, 2019
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021
Last update
Jun 16, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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