HealthyPhase 1NCT03655873

The Study of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH,in Healthy Subjects

A Phase 1 study testing HEC30654AcOH capsule in people with Healthy, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective 5-ht6 receptor antagonist, HEC30654AcOH,in healthy subjects.This test is divided into two parts, the first part is the healthy adult subjects single ascending-dose research;The second part is the healthy adult subjects multiple… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: HEC30654AcOH capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteChina
Study dates: 21 Nov 2018to 17 Dec 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
Healthy volunteers accepted
Adult

Who may be able to join

signing informed consent, and fully understanding the study's content, process，possible adverse reaction before the study beginning.
Be able to complete the study in accordance with the requirements of the study.
Subjects (including partner) which from screening to the last time of study drug dosage volunteered to take effective contraceptive measures within 6 months, see appendix for birth control measures.
Age of 18 to 45 years old male and female subjects (including 18 and 45 years of age).
Male subjects not less than 50 kg, female subjects not less than 45 kg weight.Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index (BMI) within the scope of 18 ~ 28 kg/m2 (including threshold).
Physical examination, vital signs is normal or abnormal has no clinical significance.

Who cannot join

3 months before the study daily smoking more than 5 pieces.
having allergies or allergic constitution for experiment drugs (a variety of drugs and food allergies).
Has a history of drug and/or binge drinking (drinking 14 units of alcohol every week: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100 mL).
Three months before screening blood or blood loss (> 450 mL).
28 days before the screening taking any drugs of changing liver enzymes.
Within 14 days before the screening taken any prescription drugs, over-the-counter drugs, vitamins or herbal products.

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Within 2 weeks before the screening taking any special diet (including dragon fruit, mango, pomelo, etc.) or with vigorous exercise, or other affect drug absorption, distribution, metabolism and excretion.
With the following CYP3A4, P - gp or Bcrp inhibitors or inducers, such as itraconazole, ketone health zun or definitely nida, lung, etc.
Recently, very large changes in diet or exercise habits.
Three months before taking study drug, there taken study drug and its analogues, or participated in drug clinical trials.
Having difficulty swallowing or any digestive system diseases history affecting drug absorption, excretion,etc.
Having had any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc.
Abnormal ecg that have clinical significance.
Female subjects in screening test is in lactation or have positive serum pregnancy outcomes.
Clinical laboratory examination were abnormal clinical significance, or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit, or disease of heart head blood-vessel).
Viral hepatitis (including hepatitis b and c),, treponema pallidum antibody , HIV antibody positive.
From the screening stage to study medicine had a acute disease or taken a drugs.
Within 48 hours before taking the study drug, there taken any caffeine consumed chocolate, or rich xanthine food or drinks.
Within 24 hours before taking study drug, there used any alcoholic products or alcohol-breath test was positive.
Urine drug test(Morphine and marijuana) was positive.
Neurological examination had abnormal findings, and researchers think have clinical significance.
Researchers think that doesn't fit to the study.

Trial locations and contacts

1 site in 1 country.

China1 site

First Hospital of Jilin University
Changchun, Jilin, 130000

Other trials in China

About this study

Official title: Safety, Tolerability, and Pharmacokinetics Phase ⅠStudy of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH, Following Single and Multiple Ascending Doses，Single-center, Randomized, Double-blind in Healthy Subjects

Read the detailed description

The single ascending-dose research:

There have set up seven dose group(5、10、15、30、60、90、120mg）.The first group(5mg)contains 3 health subjects，Which have been a preliminary experimental group. Each other groups contains 10 health subjects(8 health subjects take experimental drugs,2 health subjects take the placebo).Within 15min before taking the medicine and after 0.5h, 1h, 1.5h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 120h to take blood samples for pharmacokinetics(PK) detection.

The multiple ascending-dose research:

There have set up three dose group(15、30、60mg）.Each group contains 12 health subjects(10 health subjects take experimental drugs,2 health subjects take the placebo).Each dose group in D1-D7 8:00（±1h）in the morning, 18:00（±1h）, with 240 ml warm water to take corresponding study drug，but Day 8 only 8:00（±1h） in the morning take subjects drugs.Total for 15 times.on the morning of day 1 within 15minutes before the first drug and after 0.5h, 1h, 1.5h, 2h, 4h, 6h, 8h, 10h, 12h, on the morning of Day 6, Day 7 and Day 8 within 15 minutes before the drug collecting blood sample test concentration, on the morning of Day8 medication after 0.5h 1h, 1.5h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 120h collects pharmacokinetics(PK) blood samples.

Conditions: Healthy
Being tested: HEC30654AcOH capsule, Placebo capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HEC30654AcOH capsuleDrug
single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg HEC30654AcOH capsule in day1.
Multiple ascending-dose study:
15-、30-、60mgHEC30654AcOH capsule in day1-day7，2 times everyday.
Placebo capsuleDrug
single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg placebo capsule in day1.
Multiple ascending-dose study:
15-、30-、60mg placebo capsule in day1-day7，2 times everyday.

Study groups in NCT03655873
Study group	Role	What they receive
HEC30654AcOH capsule	Experimental	single ascending-dose study: Including 7 dose groups(5-、10、15-、30-、60-、90-、120mg)，Day1 ante meridiem(AM) 8:00 (±1h) with 240ml warm water to taking the experiment drug，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 Post Meridiem(PM) (±1h), with 240ml warm water to take the experiment drug On an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the experiment drug，On an empty stomach. Receives: Drug: HEC30654AcOH capsule
placebo capsule	Placebo comparator	single ascending-dose study: Including 6 dose groups(10、15-、30-、60-、90-、120mg)，Day1 morning 8:00 (±1h) with 240ml warm water to taking the placebo capsule，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 PM (±1h), with 240ml warm water to take the placebo capsule on an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the placebo capsule，on an empty stomach. Receives: Drug: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events of the single ascending-dose
To assess the safe and tolerability of the single ascending-dose
Measured: From the baseline to 6 days
Adverse events of the multiple ascending-dose
To assess the safe and tolerability of the multiple ascending-dose
Measured: From the baseline to 13 days

Secondary outcomes (6)

Maximum Plasma Concentration(Cmax)
Maximum Plasma Concentration(Cmax)of HEC30654AcOH in single ascending-dose
Measured: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Area Under the Curve(AUC)
Area Under the Curve(AUC) of HEC30654AcOH in single ascending-dose
Measured: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Maximum Peak Time(Tmax)
Maximum Peak Time(Tmax) of HEC30654AcOH in single ascending-dose
Measured: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Mean Residence Time(MRT)
Mean Residence Time(MRT) of HEC30654AcOH in single ascending-dose
Measured: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Terminal elimination half-life(T1/2)
Terminal elimination half-life(T1/2) of HEC30654AcOH in single ascending-dose
Measured: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
steady state plasma concentration(Css）
steady state plasma concentration(Css）of HEC30654AcOH in multiple ascending-dose
Measured: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h after dosing day1,then Prior to dosing（0h）of day6，day7,day8，and 0.5h，1h，1.5h，2h，4h，6h，8h，10h，12h，24h，48h，72h，96h，120h after dosing day8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 201817 Dec 2019

First posted31 Aug 2018
Study start21 Nov 2018
Primary completion17 Dec 2019
Study completion17 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03655873
Sponsor's protocol ID: HEC30654-P-01
Status last verified: Dec 2019
First submitted: 24 Aug 2018
Last updated: 1 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Safety, Tolerability, and Pharmacokinetics Phase ⅠStudy of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH, Following Single and Multiple Ascending Doses，Single-center, Randomized, Double-blind in Healthy Subjects
ClinicalTrials.gov ID: NCT03655873
Acronym / sponsor ID: HEC30654-P-01
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Nov 2018 (actual)
Primary completion: 17 Dec 2019 (actual)
Study completion: 17 Dec 2019 (actual)
First posted: 31 Aug 2018 (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.

Detailed description

The single ascending-dose research:

The multiple ascending-dose research:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HEC30654AcOH capsule	Experimental	Drug: HEC30654AcOH capsulesingle ascending-dose study: Including 7 dose groups(5-、10、15-、30-、60-、90-、120mg)，Day1 ante meridiem(AM) 8:00 (±1h) with 240ml warm water to taking the experiment drug，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 Post Meridiem(PM) (±1h), with 240ml warm water to take the experiment drug On an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the experiment drug，On an empty stomach.
placebo capsule	Placebo comparator	Drug: Placebo capsulesingle ascending-dose study: Including 6 dose groups(10、15-、30-、60-、90-、120mg)，Day1 morning 8:00 (±1h) with 240ml warm water to taking the placebo capsule，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 PM (±1h), with 240ml warm water to take the placebo capsule on an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the placebo capsule，on an empty stomach.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

signing informed consent, and fully understanding the study's content, process，possible adverse reaction before the study beginning.
Be able to complete the study in accordance with the requirements of the study.
Subjects (including partner) which from screening to the last time of study drug dosage volunteered to take effective contraceptive measures within 6 months, see appendix for birth control measures.
Age of 18 to 45 years old male and female subjects (including 18 and 45 years of age).
Male subjects not less than 50 kg, female subjects not less than 45 kg weight.Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index (BMI) within the scope of 18 ~ 28 kg/m2 (including threshold).

Key exclusion criteria (22 listed)

3 months before the study daily smoking more than 5 pieces.
having allergies or allergic constitution for experiment drugs (a variety of drugs and food allergies).
Has a history of drug and/or binge drinking (drinking 14 units of alcohol every week: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100 mL).
Three months before screening blood or blood loss (> 450 mL).
28 days before the screening taking any drugs of changing liver enzymes.

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
HEC30654AcOH capsulesingle ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg HEC30654AcOH capsule in day1. Multiple ascending-dose study: 15-、30-、60mgHEC30654AcOH capsule in day1-day7，2 times everyday.	Drug	HEC30654AcOH capsule
Placebo capsulesingle ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg placebo capsule in day1. Multiple ascending-dose study: 15-、30-、60mg placebo capsule in day1-day7，2 times everyday.	Drug	placebo capsule

Primary outcome

Adverse events of the single ascending-dose
Time frame: From the baseline to 6 days
To assess the safe and tolerability of the single ascending-dose
Adverse events of the multiple ascending-dose
Time frame: From the baseline to 13 days
To assess the safe and tolerability of the multiple ascending-dose

6 secondary outcomes

Maximum Plasma Concentration(Cmax)
Time frame: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Area Under the Curve(AUC)
Time frame: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Maximum Peak Time(Tmax)
Time frame: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Mean Residence Time(MRT)
Time frame: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
Terminal elimination half-life(T1/2)
Time frame: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing
steady state plasma concentration(Css）
Time frame: Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h after dosing day1,then Prior to dosing（0h）of day6，day7,day8，and 0.5h，1h，1.5h，2h，4h，6h，8h，10h，12h，24h，48h，72h，96h，120h after dosing day8

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 HEC30654AcOH capsule in people with Healthy, 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 6 inclusion and 22 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 events of the single ascending-dose (time frame: From the baseline to 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03655873.

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.