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COMPLETEDPHASE1

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

Safety, Tolerance and Pharmacokinetics of Hydrochloric Acid (R) -Ketamine Nasal Spray in Healthy Subjects: A Randomized, Double Blind, Placebo-Controlled Phase I Clinical Trial

NCT04108234•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 45 years

Sex

MALE

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;
+8 more criteria

Locations (1)

Beijing AnDing hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 24, 2019

Primary Completion Date

June 1, 2021

Completion Date

June 1, 2021

Last Updated

June 16, 2022

Enrollment

ACTUAL participants

Conditions

Depression

Interventions

HR071603

DRUG

placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Readiness and Progress in Emotion Regulation Therapy

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