DepressionPhase 1NCT04108234
A Study of HR071603(Ketamine Nasal Spray) in Healthy Subjects
A Phase 1 study testing HR071603 in people with Depression, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- HR071603
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2019to 1 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 12-lead ECG results in the screening period are abnormal and clinically significant
- Liver dysfunction;
- Serum creatinine > 1.2 × ULN during screening period;
Show all 18Show fewer
- 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;
- Any prescription drugs, over-the-counter drugs and health products were used within 2 weeks before screening.
- Participated in clinical trials of any drug or medical device within 3 months before screening ;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing AnDing hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
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
The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.
- Conditions
- Depression
- Being tested
- HR071603, placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR071603Drug
Also called R-ketamine
HR071603 monotherapy ,nasal spray
placeboDrug
placebo,nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | HR071603,nasal spray,dose escalation. Receives: Drug: HR071603 |
| Treatment group B | Placebo comparator | Placebo, nasal spray Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (Safety and Tolerability)
Measured: Pre-dose to Day8
Secondary outcomes (6)
Assessment of PK parameter-Area under drug-time curve (AUC)
Measured: Pre-dose to Day2
Assessment of PK parameter-peak time (Tmax)
Measured: Pre-dose to Day2
Assessment of PK parameter-peak concentration (Cmax)
Measured: Pre-dose to Day2
Assessment of PK parameter-half-life (t1/2)
Measured: Pre-dose to Day2
Assessment of PK parameter-apparent clearance rate (CL/F)
Measured: Pre-dose to Day2
Assessment of PK parameter-apparent distribution volume (Vz/F)
Measured: Pre-dose to Day2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start24 Oct 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR071603 monotherapy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108234
- Sponsor's protocol ID
- HR071603-101
- Status last verified
- Jun 2022
- First submitted
- 26 Sep 2019
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04108234
- Acronym / sponsor ID
- HR071603-101
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HR071603 monotherapy
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HR071603HR071603,nasal spray,dose escalation. |
| Treatment group B | Placebo comparator | Drug: placeboPlacebo, nasal spray |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
- 12-lead ECG results in the screening period are abnormal and clinically significant
- Liver dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR071603Also: R-ketamineHR071603 monotherapy ,nasal spray | Drug | Treatment group A |
| placeboplacebo,nasal spray | Drug | Treatment group B |
Primary outcome
Incidence of Adverse Events (Safety and Tolerability)
Time frame: Pre-dose to Day8
6 secondary outcomes
Assessment of PK parameter-Area under drug-time curve (AUC)
Time frame: Pre-dose to Day2
Assessment of PK parameter-peak time (Tmax)
Time frame: Pre-dose to Day2
Assessment of PK parameter-peak concentration (Cmax)
Time frame: Pre-dose to Day2
Assessment of PK parameter-half-life (t1/2)
Time frame: Pre-dose to Day2
Assessment of PK parameter-apparent clearance rate (CL/F)
Time frame: Pre-dose to Day2
Assessment of PK parameter-apparent distribution volume (Vz/F)
Time frame: Pre-dose to Day2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HR071603 in people with Depression, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (Safety and Tolerability) (time frame: Pre-dose to Day8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.