Clinical trial NCT04108234: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-30
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HR071603 monotherapy
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events (Safety and Tolerability)
timeFrame: Pre-dose to Day8
Secondary outcomes:
measure: Assessment of PK parameter-Area under drug-time curve (AUC)
timeFrame: Pre-dose to Day2
measure: Assessment of PK parameter-peak time (Tmax)
timeFrame: Pre-dose to Day2
measure: Assessment of PK parameter-peak concentration (Cmax)
timeFrame: Pre-dose to Day2
measure: Assessment of PK parameter-half-life (t1/2)
timeFrame: Pre-dose to Day2
measure: Assessment of PK parameter-apparent clearance rate (CL/F)
timeFrame: Pre-dose to Day2
measure: Assessment of PK parameter-apparent distribution volume (Vz/F)
timeFrame: Pre-dose to Day2
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing AnDing hospital affiliated to Capital Medical University
state: Beijing
Study officials:
References: