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

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

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: HR071603; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Anding Hospital Affiliated to Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; HR071603,nasal spray,dose escalation.	Drug: HR071603; HR071603 monotherapy ,nasal spray; Other Names: R-ketamine
Placebo Comparator: Treatment group B; Placebo, nasal spray	Drug: placebo; placebo,nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (Safety and Tolerability)	Pre-dose to Day8

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of PK parameter-Area under drug-time curve (AUC)	Pre-dose to Day2
Assessment of PK parameter-peak time (Tmax)	Pre-dose to Day2
Assessment of PK parameter-peak concentration (Cmax)	Pre-dose to Day2
Assessment of PK parameter-half-life (t1/2)	Pre-dose to Day2
Assessment of PK parameter-apparent clearance rate (CL/F)	Pre-dose to Day2
Assessment of PK parameter-apparent distribution volume (Vz/F)	Pre-dose to Day2

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: HR071603-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No