InsomniaPhase 1NCT06673927
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of YZJ-1139 in Healthy Participants
A Phase 1 study testing YZJ-1139 in people with Insomnia, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Primary Objective： 1. To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants 2. To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants Secondary objectives: To explore the safe tolerated dose of YZJ-1139, provide data support for… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Insomnia
- What is being tested?
- YZJ-1139
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 8 Mar 2019
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects, with the proportion of a single gender in each group not less than 1/3;
- Aged between 18 and 45 years (inclusive of 18 and 45 years);
- The body mass index (BMI) ranges from 19 to 24 (inclusive of 19 and 24), where BMI = weight (kg) / height squared (m²). At the time of entering the study, the weight of female volunteers must be no less than 50 kg, and that of male volunteers must be no less than 55 kg;
- Those who pass comprehensive physical examinations (vital signs, height, weight, and chest and abdominal examinations, etc.) and laboratory tests (blood routine, blood biochemistry, urine routine, electrocardiogram, infectious disease screening, etc.), and have no abnormalities or only minor abnormalities without clinical significance in 12-lead electrocardiogram, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), anteroposterior and lateral chest radiographs, etc.;
- Volunteers who can comprehend the procedures and methods of this study, are willing to strictly adhere to the clinical trial protocol to complete the trial, and sign the informed consent form.
Who cannot join
- After researchers determine that the subject has a disease that affects drug absorption, distribution, metabolism, and excretion or may reduce compliance (cardiovascular, liver, kidney, gastrointestinal, immune, hematological, endocrine, metabolic, cancer, psychiatric and neurological conditions);
- A history of specific allergic reactions (such as asthma, eczema, allergic dermatitis); known allergies to the trial drug and its excipient components; a history of drug allergies;
- A history of obstructive sleep apnea or chronic obstructive pulmonary disease;
- A history of severe unconscious hypoglycemia;
- A history of stroke, chronic epilepsy, or neurological disorders;
- A history of diminished memory or abnormal behavior;
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- A history of drug dependence within the past 2 years (smoking excluded), seizure disorders, syncope history;
- A clinically significant illness within the past month before enrollment, especially severe infections, trauma, or major surgery;
- The use of any prescription drugs or herbal medicines within the past month before enrollment, and non-prescription drugs or food supplements within the past 2 weeks;
- Regular use of sedatives, sleeping pills, or other addictive drugs, and positive urine drug screening;
- had donated blood within the 3 months prior to the study, or had severe blood loss equivalent to at least 500 mL of blood loss;
- Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive, syphilis antibody positive;
- Patients who took CYP3A enzyme inhibitors (itraconazole, erythromycin, boprevir, etc.), CYP3A enzyme inducers (rifampicin, carbamazepine) and/or CNS inhibitors (benzodiazepines, opioids, tricyclic antidepressants, etc.) 2 weeks before inclusion;
- Have a history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or about 100 ml of wine) and test positive for alcohol;
- Smokers who smoked more than 5 or equivalent cigarettes per day in the 3 months before the test and those who tested positive for nicotine should not give up smoking during the test;
- Drinking excessive tea and coffee drinks (more than 8 cups) per day;
- Drinking alcohol, eating food and drink rich in xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) or eating grapefruit, limes, etc., or food and drink prepared from them in the 3 days prior to inclusion;
- Participated in any clinical drug research or clinical trial of medical device within 3 months prior to screening;
- Pregnant and lactating women within 6 months from the subject's signature to the last administration of the study drug; Fertile women who do not use effective non-hormonal contraception (Iuds, barrier contraception with spermicide or surgical sterilization, etc.) or are unwilling to continue using these methods; Fertile men are reluctant to use physical methods of contraception; Women who were menstruating during the trial (see annex 3 for details);
- There are any subjects that the investigator considers unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics of YZJ-1139 in Healthy Participants
Primary Objective：
- To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants
- To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants
Secondary objectives:
To explore the safe tolerated dose of YZJ-1139, provide data support for the design of phase II dosing regimen
- Conditions
- Insomnia
- Being tested
- YZJ-1139, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YZJ-1139Drug
Single oral dose, 2mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg
YZJ-1139Drug
Multiple Dosing ，Each oral dose of 10 mg，20 mg，40 mg or 60 mg
PlaceboDrug
Placebo administration
| Study group | Role | What they receive |
|---|---|---|
| YZJ-1139 Single-dose Group | Experimental | Subjects will be randomized into two groups： the experimental group will receive YZJ-1139; the control group will receive placebo. Receives: Drug: YZJ-1139 |
| YZJ-1139 multiple-dose Group | Experimental | Subjects will be randomized into two groups；the experimental group will receive YZJ-1139; the control group will receive placebo once a day, 7 days. Receives: Drug: YZJ-1139; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 to Day 3 post single dose；From Day 1 to Day 14 post multiple dose；
Secondary outcomes (11)
Cmax of YZJ-1139
Cmax is defined as the maximum concentration of drug.
Measured: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
AUCinf of YZJ-1139
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Measured: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
AUClast of YZJ-1139
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
AUC0-τ of YZJ-1139
AUC0-τ is defined as the area under the concentration-time curve over the dosing interval
Measured: From Day 1 to Day 8 post multiple dose
Css,avg of YZJ-1139
Css,avg is defined as the average steady state concentration
Measured: From Day 1 to Day 8 post multiple dose
Css,min of YZJ-1139
Css,min is defined as the minimum observed concentration at steady
Measured: From Day 1 to Day 8 post multiple dose
Tmax of YZJ-1139
Tmax is defined as the time (observed time point) of Cmax
Measured: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
t1/2 of YZJ-1139
Measured: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
CL/F of YZJ-1139
CL/F is defined as the apparent oral clearance following administration of the drug
Measured: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
Vz/F of YZJ-1139
Vz/F is defined as the apparent volume of distribution of the drug
Measured: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
Rac of YZJ-1139
Rac is defined as the accumulation Ratio
Measured: From Day 1 to Day 8 post multiple dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2017
- Primary completion21 Nov 2018
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Dose escalation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673927
- Sponsor's protocol ID
- YZJ-1139-1-01
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics of YZJ-1139 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06673927
- Acronym / sponsor ID
- YZJ-1139-1-01
- Conditions
- Insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 5 Nov 2024 (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.
Primary Objective：
- To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants
- To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants
Secondary objectives:
To explore the safe tolerated dose of YZJ-1139, provide data support for the design of phase II dosing regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| YZJ-1139 Single-dose Group | Experimental | Drug: YZJ-1139Subjects will be randomized into two groups： the experimental group will receive YZJ-1139; the control group will receive placebo. |
| YZJ-1139 multiple-dose Group | Experimental | Drug: YZJ-1139, Drug: PlaceboSubjects will be randomized into two groups；the experimental group will receive YZJ-1139; the control group will receive placebo once a day, 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects, with the proportion of a single gender in each group not less than 1/3;
- Aged between 18 and 45 years (inclusive of 18 and 45 years);
- The body mass index (BMI) ranges from 19 to 24 (inclusive of 19 and 24), where BMI = weight (kg) / height squared (m²). At the time of entering the study, the weight of female volunteers must be no less than 50 kg, and that of male volunteers must be no less than 55 kg;
- Those who pass comprehensive physical examinations (vital signs, height, weight, and chest and abdominal examinations, etc.) and laboratory tests (blood routine, blood biochemistry, urine routine, electrocardiogram, infectious disease screening, etc.), and have no abnormalities or only minor abnormalities without clinical significance in 12-lead electrocardiogram, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), anteroposterior and lateral chest radiographs, etc.;
- Volunteers who can comprehend the procedures and methods of this study, are willing to strictly adhere to the clinical trial protocol to complete the trial, and sign the informed consent form.
Key exclusion criteria (20 listed)
- After researchers determine that the subject has a disease that affects drug absorption, distribution, metabolism, and excretion or may reduce compliance (cardiovascular, liver, kidney, gastrointestinal, immune, hematological, endocrine, metabolic, cancer, psychiatric and neurological conditions);
- A history of specific allergic reactions (such as asthma, eczema, allergic dermatitis); known allergies to the trial drug and its excipient components; a history of drug allergies;
- A history of obstructive sleep apnea or chronic obstructive pulmonary disease;
- A history of severe unconscious hypoglycemia;
- A history of stroke, chronic epilepsy, or neurological disorders;
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 |
|---|---|---|
| YZJ-1139Single oral dose, 2mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg | Drug | YZJ-1139 Single-dose Group |
| YZJ-1139Multiple Dosing ，Each oral dose of 10 mg，20 mg，40 mg or 60 mg | Drug | YZJ-1139 multiple-dose Group |
| PlaceboPlacebo administration | Drug | YZJ-1139 multiple-dose Group |
Primary outcome
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 to Day 3 post single dose；From Day 1 to Day 14 post multiple dose；
11 secondary outcomes
Cmax of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
AUCinf of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
AUClast of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
AUC0-τ of YZJ-1139
Time frame: From Day 1 to Day 8 post multiple dose
Css,avg of YZJ-1139
Time frame: From Day 1 to Day 8 post multiple dose
Css,min of YZJ-1139
Time frame: From Day 1 to Day 8 post multiple dose
Tmax of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
t1/2 of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
CL/F of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
Vz/F of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose
Rac of YZJ-1139
Time frame: From Day 1 to Day 8 post multiple dose
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 10 Feb 2025.
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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 YZJ-1139 in people with Insomnia, run by Shanghai Haiyan Pharmaceutical Technology 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 5 inclusion and 20 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 10 Feb 2025. 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. 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?
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From Day 1 to Day 3 post single dose；From Day 1 to Day 14 post multiple dose；). 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 10 Feb 2025.