Major Depressive DisorderPhase 1NCT04591301

The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects

A Phase 1 study testing HEC113995 PA•H2O tablets in people with Major Depressive Disorder, 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

The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Male and Female Subjects Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: HEC113995 PA•H2O tablets
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 6 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

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
3. Subjects aged between 18 and 45 (both inclusive) years old.
4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
5. 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

1.Subjects with serum creatinine, ALT and AST levels ≥1.5 times of the upper limit of normal value at screening.
2.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.
3. 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 epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
4. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique.
5. Use of any prescription or non-prescription medications within 14 days prior to initial dosing#Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
6. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.

Show all 13Show fewer

7. Positive results from urine drug screen test.
8. 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.
9.Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study.
10. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
11. Subjects who plan to receive or have had organ transplants.
12. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
13. 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.

China1 site

Shanghai Xuhui Central Hospital
Shanghai

Other trials in China

About this study

Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of HEC113995 PA•H2O Tablets in Healthy Subjects

The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Male and Female Subjects

Conditions: Major Depressive Disorder
Being tested: HEC113995 PA•H2O tablets, Placebo tablets
Medical subject headings: Depressive Disorder, Major

What participants receive

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

HEC113995 PA•H2O tabletsDrug
Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Placebo tabletsDrug
Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Study groups in NCT04591301
Study group	Role	What they receive
HEC113995 PA•H2O 2.5mg	Experimental	Healthy subjects are given HEC113995 PA•H2O 2.5 mg in a single dose. Receives: Drug: HEC113995 PA•H2O tablets
HEC113995 PA•H2O 5mg	Active comparator	Healthy subjects are given HEC113995 PA•H2O 5 mg in a single dose. Receives: Drug: HEC113995 PA•H2O tablets
HEC113995 PA•H2O 10mg	Active comparator	Healthy subjects are given HEC113995 PA•H2O 10 mg in a single dose. Receives: Drug: HEC113995 PA•H2O tablets
HEC113995 PA•H2O 20mg	Active comparator	Healthy subjects are given HEC113995 PA•H2O 20 mg in a single dose. Receives: Drug: HEC113995 PA•H2O tablets
HEC113995 PA•H2O 40mg	Active comparator	Healthy subjects are given HEC113995 PA•H2O 40 mg in a single dose. Receives: Drug: HEC113995 PA•H2O tablets
HEC113995 PA•H2O 60mg	Active comparator	Healthy subjects are given HEC113995 PA•H2O 60 mg in a single dose. Receives: Drug: HEC113995 PA•H2O tablets
HEC113995 PA•H2O 80mg	Active comparator	Healthy subjects are given HEC113995 PA•H2O 80 mg in a single dose. Receives: Drug: HEC113995 PA•H2O tablets
placebo	Placebo comparator	Healthy subjects are given placebo in a single dose. Receives: Drug: Placebo tablets

What is being measured

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

Safety and Tolerability of HEC113995 PA•H2O by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose
To investigate the safety and tolerability of HEC113995 PA•H2O by assessment of AEs (non-serious and serious) following administration in SAD
Measured: up to 7 days

Secondary outcomes (7)

PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Measured: up to 144 hours
PK parameters - Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC113995 PA•H2O
Measured: up to 144 hours
PK parameters -tmax
time to peak
Measured: up to 144 hours
PK parameters -t½
apparent terminal elimination half-life
Measured: up to 144 hours
PK parameters -Vz/F
apparent volume of distribution
Measured: up to 144 hours
PK parameters - MRT
the Mean Residence Time
Measured: up to 144 hours
PK parameters -CL/F
the Apparent Clearance
Measured: up to 144 hours

Timeline

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

4 Jul 20196 Dec 2019

First posted19 Oct 2020
Study start4 Jul 2019
Primary completion6 Dec 2019
Study completion6 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04591301
Sponsor's protocol ID: HEC113995PA•H2O-P-01/CRC-C1910
Status last verified: Oct 2020
First submitted: 15 Oct 2020
Last updated: 28 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of HEC113995 PA•H2O Tablets in Healthy Subjects
ClinicalTrials.gov ID: NCT04591301
Acronym / sponsor ID: HEC113995PA•H2O-P-01/CRC-C1910
Conditions: Major Depressive Disorder
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: 6 Dec 2019 (actual)
Study completion: 6 Dec 2019 (actual)
First posted: 19 Oct 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.

The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Male and Female Subjects

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
HEC113995 PA•H2O 2.5mg	Experimental	Drug: HEC113995 PA•H2O tabletsHealthy subjects are given HEC113995 PA•H2O 2.5 mg in a single dose.
HEC113995 PA•H2O 5mg	Active comparator	Drug: HEC113995 PA•H2O tabletsHealthy subjects are given HEC113995 PA•H2O 5 mg in a single dose.
HEC113995 PA•H2O 10mg	Active comparator	Drug: HEC113995 PA•H2O tabletsHealthy subjects are given HEC113995 PA•H2O 10 mg in a single dose.
HEC113995 PA•H2O 20mg	Active comparator	Drug: HEC113995 PA•H2O tabletsHealthy subjects are given HEC113995 PA•H2O 20 mg in a single dose.
HEC113995 PA•H2O 40mg	Active comparator	Drug: HEC113995 PA•H2O tabletsHealthy subjects are given HEC113995 PA•H2O 40 mg in a single dose.
HEC113995 PA•H2O 60mg	Active comparator	Drug: HEC113995 PA•H2O tabletsHealthy subjects are given HEC113995 PA•H2O 60 mg in a single dose.
HEC113995 PA•H2O 80mg	Active comparator	Drug: HEC113995 PA•H2O tabletsHealthy subjects are given HEC113995 PA•H2O 80 mg in a single dose.
placebo	Placebo comparator	Drug: Placebo tabletsHealthy subjects are given placebo in a single dose.

Who may qualify

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

Key inclusion criteria (5 listed)

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
3. Subjects aged between 18 and 45 (both inclusive) years old.
4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
5. 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 (13 listed)

1.Subjects with serum creatinine, ALT and AST levels ≥1.5 times of the upper limit of normal value at screening.
2.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.
3. 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 epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
4. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique.
5. Use of any prescription or non-prescription medications within 14 days prior to initial dosing#Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.

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
HEC113995 PA•H2O tabletsEach dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.	Drug	HEC113995 PA•H2O 10mg, HEC113995 PA•H2O 2.5mg, HEC113995 PA•H2O 20mg, HEC113995 PA•H2O 40mg, HEC113995 PA•H2O 5mg, HEC113995 PA•H2O 60mg, HEC113995 PA•H2O 80mg
Placebo tabletsPlacebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.	Drug	placebo

Primary outcome

Safety and Tolerability of HEC113995 PA•H2O by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose
Time frame: up to 7 days
To investigate the safety and tolerability of HEC113995 PA•H2O by assessment of AEs (non-serious and serious) following administration in SAD

7 secondary outcomes

PK parameters - AUC0-∞
Time frame: up to 144 hours
PK parameters - Cmax
Time frame: up to 144 hours
PK parameters -tmax
Time frame: up to 144 hours
PK parameters -t½
Time frame: up to 144 hours
PK parameters -Vz/F
Time frame: up to 144 hours
PK parameters - MRT
Time frame: up to 144 hours
PK parameters -CL/F
Time frame: up to 144 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 28 Oct 2020.

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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 HEC113995 PA•H2O tablets in people with Major Depressive Disorder, 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 28 Oct 2020. 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?

Safety and Tolerability of HEC113995 PA•H2O by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose (time frame: up to 7 days). 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 NCT04591301.

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 28 Oct 2020.