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

NCT04108234 | Completed Phase 1

• 1 other identifier: HR071603-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (Safety and Tolerability)

  Pre-dose to Day8

Secondary Outcomes (6)

• 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

Study Arms (2)

Treatment group A

EXPERIMENTAL

HR071603,nasal spray,dose escalation.

Drug: HR071603

Treatment group B

PLACEBO COMPARATOR

Placebo, nasal spray

Drug: placebo

Interventions

HR071603 DRUG

HR071603 monotherapy ,nasal spray

Also known as: R-ketamine

Treatment group A

placebo DRUG

placebo,nasal spray

Treatment group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Healthy males aged between 18 and 45 (including both ends);
• Weight ≥ 50kg, body mass index (BMI) in the range of 18.5 \~ 23.9 (including both ends);
• During the trial and within 30 days after the administration, willing to take contraceptive measures and ensure that no sperm is donated.

You may not qualify if:

• A subject considered by the investigator to be unsuitable for nasal spray administration;
• Allergic to any component of the study drug;
• The underlying disease is not suitable for participation in the trial;
• lead ECG results in the screening period are abnormal and clinically significant
• Liver dysfunction;
• Serum creatinine \> 1.2 × ULN during screening period;
• Screening for infectious diseases screening hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, human immunodeficiency virus (HIV) antibody test positive;
• Subject has been thoroughly examined, and the results are abnormal and clinically significant;
• Major operations were performed within 3 months before the screening period.
• 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;
• Positive urine drug test;
• The alcohol breath test is positive; or the average daily intake of alcohol exceeds 15g;
• Nicotine test is positive;
• History of drug abuse or alcohol abuse;
• In the past three months, over five cups of coffee or tea per day were consumed in an average;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing AnDing hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR071603 monotherapy

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: October 24, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

CN (1)