HealthyPhase 1NCT03943251
The Study of a Selective Serotonin Partial Agonist and Reuptake Inhibitors, HEC113995PA•H2O,in Healthy Subjects
A Phase 1 study testing HEC113995PA•H2O tablet in people with Healthy, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective Serotonin partial agonist and reuptake inhibitors, HEC113995PA•H2O,in healthy subjects.This study is the healthy adult subjects single ascending-dose research. 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?
- HEC113995PA•H2O tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2019to 11 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
- Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
- Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
- When signing the informed consent, 18 years old ≤the age≤45 years old, gender is not limited.
- Male body weight ≥50kg, female body weight ≤45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
- No clinical significance of vital signs, physical examination, laboratory examination, chest X-ray (posterior and anterior) and electrocardiogram results.
Who cannot join
- The serum creatinine, ALT and AST levels ≥1.5 times of the normal upper limit in the screening period.
- The HbsAg, anti-HCV, HIV-antibody or syphilis antibody is positive in screening.
- Patients with clinical significance of the following diseases, including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases, epilepsy, bipolar disorder/mania, high intraocular pressure or acute angle-closure glaucoma disease history.
- Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
- Any prescription or over-the-counter medication taken within 14 days prior to starting the study drug, or any drug that inhibits or induces the liver to metabolize the drug within 28 days [e.g., inducer - the barbiturates, rifampicin, carbamazepine, phenytoin, omeprazole, griseofulvin, ammonia methyl propyl ester, etc.; inhibitors - large ring lactone class antibiotic (such as erythromycin, clarithromycin, etc.), azole antifungal drugs (such as ketone health zun, itraconazole, etc.), fluoroquinolone (e.g., ciprofloxacin, sand magnitude), calcium channel blockers (such as verapamil, diltiazem, etc.), H1 receptor antagonist (e.g., astemizole, etc.), H2 receptor antagonist (e.g., cimetidine, etc.), SSRI antidepressants (such as fluoxetine, fluvoxamine, etc.), benzodiazepines a tranquilizer, clopidogrel, gemfibrozil, deferasirox, teriflunomide, telithromycin, trimethoprim, HMG-CoA reductase inhibitors (such as lovastatin, simvastatin, etc.), nitroimidazoles, etc.
- Those who ingested food or drink containing caffeine, xanthine, alcohol or grapefruit within 48 hours before taking the study drug.
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- The urine drug abuse screening(morphine, tetrahydrocannabinolate, methamphetamine, dimethylene dioxyamphetamine, ketamine, and cocaine) is positive.
- Intemperant or regular drinkers within 3 months prior to the study, i.e., those who consumed more than 21 units of alcohol per week (1 unit =360mL beer or 45mL spirit with 40% alcohol or 150mL wine), or those who were positive on the alcohol breath test.
- A heavy smoker or smokers who smoke more than 10 cigarettes per day within 3 months prior to administration or who fail to comply with the no smoking regulation during the study.
- Those who had a blood donation or blood loss of >400mL within one month before taking the study drug.
- Those who plan to receive an organ transplant or have had one.
- Those who have participated in clinical trials of other drugs within 3 months before randomization.
- Subjects considered by the investigator to have other factors unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Shanghai xuhui district central hospital
Shanghai, Shanghai Municipality
About this study
Official title: Safety, Tolerability, and Pharmacokinetics Phase ⅠStudy of a Selective Serotonin Partial Agonist and Reuptake Inhibitors, HEC113995PA•H2O, Following Single Ascending Doses，Single-center, Randomized, Double-blind in Healthy Subjects
This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective Serotonin partial agonist and reuptake inhibitors, HEC113995PA•H2O,in healthy subjects.This study is the healthy adult subjects single ascending-dose research.
Read the detailed description
There have set up seven dose group(2.5、5、10、20、40、60、80mg）.The first group(2.5mg)contains 8 health subjects(6 health subjects take experimental drugs,2 health subjects take the placebo). Other groups contains 10 health subjects(8 health subjects take experimental drugs,2 health subjects take the placebo).Within 30min before taking the medicine and after 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 36h, 48h,72h to take blood samples for pharmacokinetics(PK) detection.
- Conditions
- Healthy
- Being tested
- HEC113995PA•H2O tablet, Placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC113995PA•H2O tabletDrug
2.5-、5-、10-、20-、40-、60-、80mg HEC113995PA•H2O tablet in day1.
Placebo tabletDrug
2.5-、5-、10-、20-、40-、60-、80mg Placebo tablet in day1.
| Study group | Role | What they receive |
|---|---|---|
| HEC113995PA•H2O tablet | Experimental | Including 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. Receives: Drug: HEC113995PA•H2O tablet |
| placebo tablet | Placebo comparator | Including 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. Receives: Drug: Placebo tablet |
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 day4
Secondary outcomes (3)
Maximum Plasma Concentration(Cmax)
Maximum Plasma Concentration(Cmax)of HEC113995PA•H2O in single ascending-dose
Measured: Prior to dosing（0.5h）and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing
Area Under the Curve(AUC)
Area Under the Curve(AUC) of HEC113995PA•H2O in single ascending-dose
Measured: Prior to dosing（0.5h）and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing
Maximum Peak Time(Tmax)
Maximum Peak Time(Tmax) of HEC113995PA•H2O in single ascending-dose
Measured: Prior to dosing（0.5h）and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start4 Jul 2019
- Primary completion11 Dec 2019
- Study completion11 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
- 69 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
- NCT03943251
- Sponsor's protocol ID
- HEC113995PA•H2O-P-01/CRC-C19
- Status last verified
- May 2021
- First submitted
- 7 May 2019
- Last updated
- 13 May 2021
- Results posted
- 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 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics Phase ⅠStudy of a Selective Serotonin Partial Agonist and Reuptake Inhibitors, HEC113995PA•H2O, Following Single Ascending Doses，Single-center, Randomized, Double-blind in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03943251
- Acronym / sponsor ID
- HEC113995PA•H2O-P-01/CRC-C19
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 9 May 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.
This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective Serotonin partial agonist and reuptake inhibitors, HEC113995PA•H2O,in healthy subjects.This study is the healthy adult subjects single ascending-dose research.
Detailed description
There have set up seven dose group(2.5、5、10、20、40、60、80mg）.The first group(2.5mg)contains 8 health subjects(6 health subjects take experimental drugs,2 health subjects take the placebo). Other groups contains 10 health subjects(8 health subjects take experimental drugs,2 health subjects take the placebo).Within 30min before taking the medicine and after 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 36h, 48h,72h to take blood samples for pharmacokinetics(PK) detection.
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 |
|---|---|---|
| HEC113995PA•H2O tablet | Experimental | Drug: HEC113995PA•H2O tabletIncluding 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
| placebo tablet | Placebo comparator | Drug: Placebo tabletIncluding 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
- Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
- When signing the informed consent, 18 years old ≤the age≤45 years old, gender is not limited.
- Male body weight ≥50kg, female body weight ≤45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
- No clinical significance of vital signs, physical examination, laboratory examination, chest X-ray (posterior and anterior) and electrocardiogram results.
Key exclusion criteria (13 listed)
- The serum creatinine, ALT and AST levels ≥1.5 times of the normal upper limit in the screening period.
- The HbsAg, anti-HCV, HIV-antibody or syphilis antibody is positive in screening.
- Patients with clinical significance of the following diseases, including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases, epilepsy, bipolar disorder/mania, high intraocular pressure or acute angle-closure glaucoma disease history.
- Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
- Any prescription or over-the-counter medication taken within 14 days prior to starting the study drug, or any drug that inhibits or induces the liver to metabolize the drug within 28 days [e.g., inducer - the barbiturates, rifampicin, carbamazepine, phenytoin, omeprazole, griseofulvin, ammonia methyl propyl ester, etc.; inhibitors - large ring lactone class antibiotic (such as erythromycin, clarithromycin, etc.), azole antifungal drugs (such as ketone health zun, itraconazole, etc.), fluoroquinolone (e.g., ciprofloxacin, sand magnitude), calcium channel blockers (such as verapamil, diltiazem, etc.), H1 receptor antagonist (e.g., astemizole, etc.), H2 receptor antagonist (e.g., cimetidine, etc.), SSRI antidepressants (such as fluoxetine, fluvoxamine, etc.), benzodiazepines a tranquilizer, clopidogrel, gemfibrozil, deferasirox, teriflunomide, telithromycin, trimethoprim, HMG-CoA reductase inhibitors (such as lovastatin, simvastatin, etc.), nitroimidazoles, etc.
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 |
|---|---|---|
| HEC113995PA•H2O tablet2.5-、5-、10-、20-、40-、60-、80mg HEC113995PA•H2O tablet in day1. | Drug | HEC113995PA•H2O tablet |
| Placebo tablet2.5-、5-、10-、20-、40-、60-、80mg Placebo tablet in day1. | Drug | placebo tablet |
Primary outcome
Adverse events of the single ascending-dose
Time frame: From the baseline to day4
To assess the safe and tolerability of the single ascending-dose
3 secondary outcomes
Maximum Plasma Concentration(Cmax)
Time frame: Prior to dosing（0.5h）and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing
Area Under the Curve(AUC)
Time frame: Prior to dosing（0.5h）and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing
Maximum Peak Time(Tmax)
Time frame: Prior to dosing（0.5h）and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing
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 13 May 2021.
- 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 HEC113995PA•H2O tablet 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 5 inclusion and 13 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 13 May 2021. 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 day4). 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 13 May 2021.