InsomniaPhase 1NCT04667429
the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets
A Phase 1 study testing Food and HEC83518 in people with Insomnia, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Food and HEC83518
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2021to 9 Jul 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- Subjects aged between 18 and 45 (both inclusive) years old.
- Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Who cannot join
- Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
- Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
- Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
- Subjects with history of sleep-related illness.
- Subjects with history of severe involuntary hypoglycemia
- Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
Show all 15Show fewer
- Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test.
- History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
- Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
- Subjects who plan to receive or have had organ transplants.
- Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 15 Subjects who participated in another clinical trial within 3 months prior to initial dosing.
- 16.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 Tablets in Healthy Chinese Subjects
Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects
- Conditions
- Insomnia
- Being tested
- Food, HEC83518, 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.
FoodOther
HEC83518 40mg will be taken orally fasted or with food
HEC83518Drug
HEC83518 will be taken orally before sleep for 15 days
placeboDrug
The placebo will be administered before sleep for 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Food effect | Experimental | HEC83518 40mg will be administered fasted, or with high-fat meal for once. Receives: Other: Food |
| Multiple Ascending Doses-HEC83518 20mg | Experimental | HEC83518 20mg will be administered before sleep for 15 days . Receives: Drug: HEC83518 |
| Multiple Ascending Doses-HEC83518 40mg | Experimental | HEC83518 40mg will be administered before sleep for 15 days . Receives: Drug: HEC83518 |
| Multiple Ascending Doses-HEC83518 80mg | Experimental | HEC83518 80mg will be administered before sleep for 15 days . Receives: Drug: HEC83518 |
| Multiple Ascending Doses-placebo | Placebo comparator | Placebo will be administered before sleep for 15 days . Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
To assess the safety and tolerability of therapy
Measured: up to 34 days
Secondary outcomes (10)
Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )
Measured: up to 72 hours
Maximum Plasma Concentration ( Cmax)
Measured: up to 72 hours
Time to peak(tmax)
Measured: up to 72 hours
Apparent terminal elimination half-life(t½)
Measured: up to 72 hours
Apparent volume of distribution(Vz/F)
Measured: up to 72 hours
The Mean Residence Time#(MRT)
Measured: up to 72 hours
The Apparent Clearance (CL/F)
Measured: up to 72 hours
The Accumulation Ratio(R)
Measured: up to 60 hours
Food Effect on the Cmax
Measured: up to 72 hours
Food Effect on the AUC
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start18 Jan 2021
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
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.
- More trials run by Sunshine Lake Pharma 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667429
- Sponsor's protocol ID
- HEC83518-P-02 / CRC-C2048
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 Tablets in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04667429
- Acronym / sponsor ID
- HEC83518-P-02 / CRC-C2048
- Conditions
- Insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 14 Dec 2020 (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.
Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Food effect | Experimental | Other: FoodHEC83518 40mg will be administered fasted, or with high-fat meal for once. |
| Multiple Ascending Doses-HEC83518 20mg | Experimental | Drug: HEC83518HEC83518 20mg will be administered before sleep for 15 days . |
| Multiple Ascending Doses-HEC83518 40mg | Experimental | Drug: HEC83518HEC83518 40mg will be administered before sleep for 15 days . |
| Multiple Ascending Doses-HEC83518 80mg | Experimental | Drug: HEC83518HEC83518 80mg will be administered before sleep for 15 days . |
| Multiple Ascending Doses-placebo | Placebo comparator | Drug: placeboPlacebo will be administered before sleep for 15 days . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- Subjects aged between 18 and 45 (both inclusive) years old.
- Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Key exclusion criteria (15 listed)
- Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
- Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
- Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
- Subjects with history of sleep-related illness.
- Subjects with history of severe involuntary hypoglycemia
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 |
|---|---|---|
| FoodHEC83518 40mg will be taken orally fasted or with food | Other | Food effect |
| HEC83518HEC83518 will be taken orally before sleep for 15 days | Drug | Multiple Ascending Doses-HEC83518 20mg, Multiple Ascending Doses-HEC83518 40mg, Multiple Ascending Doses-HEC83518 80mg |
| placeboThe placebo will be administered before sleep for 15 days. | Drug | Multiple Ascending Doses-placebo |
Primary outcome
Adverse event
Time frame: up to 34 days
To assess the safety and tolerability of therapy
10 secondary outcomes
Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )
Time frame: up to 72 hours
Maximum Plasma Concentration ( Cmax)
Time frame: up to 72 hours
Time to peak(tmax)
Time frame: up to 72 hours
Apparent terminal elimination half-life(t½)
Time frame: up to 72 hours
Apparent volume of distribution(Vz/F)
Time frame: up to 72 hours
The Mean Residence Time#(MRT)
Time frame: up to 72 hours
The Apparent Clearance (CL/F)
Time frame: up to 72 hours
The Accumulation Ratio(R)
Time frame: up to 60 hours
Food Effect on the Cmax
Time frame: up to 72 hours
Food Effect on the AUC
Time frame: up to 72 hours
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 1 May 2026.
- Individual participant dataSharing planned: No
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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 Food and HEC83518 in people with Insomnia, run by Sunshine Lake Pharma 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 15 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 1 May 2026. 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?
Adverse event (time frame: up to 34 days). 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 1 May 2026.