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CompletedPhase 1

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

NCT04108234 · Jiangsu HengRui Medicine Co., Ltd.

Closed to entry
Status
Not accepting participants
Phase 1
Phase
50
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence of Adverse Events (Safety and Tolerability)

    Measured over Pre-dose to Day8

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
MALE
Sex
Accepted
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.

Where

1 study site

FacilityCityRegionCountry
Beijing AnDing hospital affiliated to Capital Medical UniversityBeijingBeijing MunicipalityChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04108234 on ClinicalTrials.gov →

Last updated in the registry 2022-06-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication