Nonalcoholic Steatohepatitis (NASH)Phase 1NCT04546984
Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects
A Phase 1 study testing HEC96719 in people with Nonalcoholic Steatohepatitis (NASH), run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 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
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- HEC96719
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2020to 29 Dec 2020
- 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(including the critical value), 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, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.
Who cannot join
- Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
- Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test.
- 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.
- 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: A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics，and Randomized, Open-label，Crossover, Food Effect Study of HEC96719 in Healthy Chinese Subjects
The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- HEC96719
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC96719Drug
Part 2：Mulltiple doses up to 10 days
| Study group | Role | What they receive |
|---|---|---|
| Single dose of HEC96719 （Part 1，Fed/Fasting） | Experimental | Following an overnight fast of at least 10 hours, a single dose of HEC96719 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. Receives: Drug: HEC96719 |
| Mulltiple doses HEC96719（ Part 2, Cohort 1） | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo Receives: Drug: HEC96719 |
| Mulltiple doses HEC96719（ Part 2, Cohort 2） | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo Receives: Drug: HEC96719 |
| Mulltiple doses HEC96719（ Part 2, Cohort 3） | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo Receives: Drug: HEC96719 |
| Mulltiple doses HEC96719（ Part 2, Cohort 4） | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo Receives: Drug: HEC96719 |
| Mulltiple doses HEC96719（ Part 2, Cohort 5） | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo Receives: Drug: HEC96719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events
To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD
Measured: up to 17 days
Secondary outcomes (4)
Cmax
Maximum Plasma Concentration(Cmax)of HEC96719
Measured: up to 96 hours
AUC
Area Under the Curve(AUC) of HEC96719
Measured: up to 96 hours
Tmax
Maximum Peak Time(Tmax) of HEC96719
Measured: up to 96 hours
T1/2
Maximum Peak Time(Tmax) of HEC96719
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start14 Sep 2020
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT04546984
- Sponsor's protocol ID
- HEC96719-P-02/CRC-C2028
- Status last verified
- May 2021
- First submitted
- 6 Sep 2020
- Last updated
- 7 May 2021
- 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 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics，and Randomized, Open-label，Crossover, Food Effect Study of HEC96719 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04546984
- Acronym / sponsor ID
- HEC96719-P-02/CRC-C2028
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 14 Sep 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, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single dose of HEC96719 （Part 1，Fed/Fasting） | Experimental | Drug: HEC96719Following an overnight fast of at least 10 hours, a single dose of HEC96719 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| Mulltiple doses HEC96719（ Part 2, Cohort 1） | Experimental | Drug: HEC96719Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 2） | Experimental | Drug: HEC96719Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 3） | Experimental | Drug: HEC96719Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 4） | Experimental | Drug: HEC96719Healthy subjects receive multiple doses of HEC96719 or matching placebo |
| Mulltiple doses HEC96719（ Part 2, Cohort 5） | Experimental | Drug: HEC96719Healthy subjects receive multiple doses of HEC96719 or matching placebo |
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(including the critical value), 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, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.
Key exclusion criteria (7 listed)
- Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
- Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test.
- Donate blood or lose blood 400 mL or more within 1 month 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 |
|---|---|---|
| HEC96719Part 2：Mulltiple doses up to 10 days | Drug | Mulltiple doses HEC96719（ Part 2, Cohort 1）, Mulltiple doses HEC96719（ Part 2, Cohort 2）, Mulltiple doses HEC96719（ Part 2, Cohort 3）, Mulltiple doses HEC96719（ Part 2, Cohort 4）, Mulltiple doses HEC96719（ Part 2, Cohort 5）, Single dose of HEC96719 （Part 1，Fed/Fasting） |
Primary outcome
Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events
Time frame: up to 17 days
To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD
4 secondary outcomes
Cmax
Time frame: up to 96 hours
AUC
Time frame: up to 96 hours
Tmax
Time frame: up to 96 hours
T1/2
Time frame: up to 96 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 7 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 HEC96719 in people with Nonalcoholic Steatohepatitis (NASH), 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 7 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 7 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. 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 HEC96719 by Assessment of the Number of Adverse Events (time frame: up to 17 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 7 May 2021.