Non-alcoholic Fatty Liver DiseasePhase 1NCT04422496
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects
A Phase 1 study testing HEC96719 in people with Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in Australia.
Trial summary
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- What is being tested?
- HEC96719
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Aug 2020to 23 Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception
- Able to comprehend and willing to provide a written Informed Consent Form (ICF) and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- History of gallstone disease or diseases affecting the bile ducts.
- History of inflammation, ulceration, bleeding affecting the gastrointestinal tract.
- Alanine transaminase (ALT) or Glutamic oxalacetic transaminase(AST) is out of the normal range.
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- Bilirubin is more than 1.5 x upper limit of normal.
- Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, and/or human immunodeficiency virus antibodies .
- History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-tuberculosis(TB) testing performed at screening.
- Positive QuantiFERON®-tuberculosis(TB) indicating possible tuberculosis infection.
- Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the course of the study.
- History of clinically significant opportunistic infection e.g. invasive candidiasis or pneumocystis pneumonia.
- Serious local infection e.g. cellulitis, abscess, or systemic infection e.g. septicemia, within 3 months prior to screening.
- Presence of fever (body temperature >37.6 °C) e.g. a fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing.
- Subjects who are scheduled to receive an organ transplant or have received an organ transplant;
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to Check-in.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- History of drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening, or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening.
- Alcohol consumption of > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
- Positive urine drugs of abuse screen at Screening or Check-in.
- Smokers of more than 5 cigarettes per week or positive cotinine test at Screening or Check-in.
- Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges within 7 days prior to Check-in, consumption of caffeine-containing foods and beverages within 72 hours prior to Check-in, or consumption of alcohol within 48 hours prior to Check-in.
- Receipt of blood products within 2 months prior to Check-in.
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study, and have previously received the investigational product.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC96719 Tablets in Healthy Subjects
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects
Read the detailed description
This study consists of a single-dose study and a multiple-dose study, both using a single-center, randomized, double-blind, placebo-controlled, dose-escalation design： I. Single-Dose Study There will be a total of 6 dose cohorts. Each cohort will include 10 subjects, of which 8 receives HEC96719 tablets and 2 receives placebo, regardless of gender. Each subject will only participate in one dose cohort. Each cohort will be divided into 2 group. The first group consists of 2 sentinels, one receiving active and one placebo. The second group will consist of the remainder of the cohort (7 active and 1 placebo) and, following review of the available safety data, will be dosed 48 hours after the sentinel group. Subjects can leave the pharmacy after their biological samples are collected on day 3. The last safety follow-up visit is to be performed on day 7±1 via telephone. Subjects in each cohort will receive a single dose of HEC96719 or placebo in the fasted state on day 1, and safety evaluation is to be performed on day 3 and 7.
II. Multi-Dose Study There will be a total of 3 dose cohorts. Each cohort will consist of 12 subjects, of which 10 receive HEC96719 tablets and 2 receive placebo, the dose regimen will comprise no less than once a day and will not exceed 4 times daily dosing for 7 consecutive days (study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study). Each subject will only participate in one dose cohort. Subjects will reside at the pharmacy from the day before dosing (D-1) to 96 h after the last dose. Subjects can leave pharmacy after their biological samples are collected. The last safety follow-up visit is to be performed 168±24 h after the last dose via telephone.
- 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
single-Dose Study: Each dose of HEC96719 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study.
| Study group | Role | What they receive |
|---|---|---|
| HEC96719 tablets | Experimental | part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B: There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg Receives: Drug: HEC96719 |
| placebo tablets | Placebo comparator | part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B:There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg Receives: Drug: HEC96719 |
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: Baseline to day 21
Secondary outcomes (7)
Cmax
maximum observed plasma concentration of HEC96719
Measured: predose to 96 hour after dosing
AUC
area under the plasma concentration-time curve (AUC)
Measured: predose to 96 hour after dosing
T½
apparent terminal elimination half-life
Measured: predose to 96 hour after dosing
Tmax
time of the maximum observed plasma concentration
Measured: predose to 96 hour after dosing
C4
7α-hydroxy-4-cholestene-3-one
Measured: predose to 48 hour after dosing
FGF19
Fibroblast growth factor 19
Measured: predose to 48 hour after dosing
CL/F
apparent oral clearance
Measured: predose to 96 hour 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 Jun 2020
- Study start10 Aug 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Rankin, Doctor, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422496
- Sponsor's protocol ID
- HEC96719-P-03
- Status last verified
- May 2021
- First submitted
- 1 Jun 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC96719 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04422496
- Acronym / sponsor ID
- HEC96719-P-03
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 9 Jun 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, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects
Detailed description
This study consists of a single-dose study and a multiple-dose study, both using a single-center, randomized, double-blind, placebo-controlled, dose-escalation design： I. Single-Dose Study There will be a total of 6 dose cohorts. Each cohort will include 10 subjects, of which 8 receives HEC96719 tablets and 2 receives placebo, regardless of gender. Each subject will only participate in one dose cohort. Each cohort will be divided into 2 group. The first group consists of 2 sentinels, one receiving active and one placebo. The second group will consist of the remainder of the cohort (7 active and 1 placebo) and, following review of the available safety data, will be dosed 48 hours after the sentinel group. Subjects can leave the pharmacy after their biological samples are collected on day 3. The last safety follow-up visit is to be performed on day 7±1 via telephone. Subjects in each cohort will receive a single dose of HEC96719 or placebo in the fasted state on day 1, and safety evaluation is to be performed on day 3 and 7.
II. Multi-Dose Study There will be a total of 3 dose cohorts. Each cohort will consist of 12 subjects, of which 10 receive HEC96719 tablets and 2 receive placebo, the dose regimen will comprise no less than once a day and will not exceed 4 times daily dosing for 7 consecutive days (study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study). Each subject will only participate in one dose cohort. Subjects will reside at the pharmacy from the day before dosing (D-1) to 96 h after the last dose. Subjects can leave pharmacy after their biological samples are collected. The last safety follow-up visit is to be performed 168±24 h after the last dose via telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEC96719 tablets | Experimental | Drug: HEC96719part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B: There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg |
| placebo tablets | Placebo comparator | Drug: HEC96719part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B:There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception
- Able to comprehend and willing to provide a written Informed Consent Form (ICF) and to abide by the study restrictions.
Key exclusion criteria (29 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- History of gallstone disease or diseases affecting the bile ducts.
- History of inflammation, ulceration, bleeding affecting the gastrointestinal tract.
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 |
|---|---|---|
| HEC96719single-Dose Study: Each dose of HEC96719 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study. | Drug | HEC96719 tablets, placebo tablets |
Primary outcome
Adverse event
Time frame: Baseline to day 21
To assess the safety and tolerability of therapy.
7 secondary outcomes
Cmax
Time frame: predose to 96 hour after dosing
AUC
Time frame: predose to 96 hour after dosing
T½
Time frame: predose to 96 hour after dosing
Tmax
Time frame: predose to 96 hour after dosing
C4
Time frame: predose to 48 hour after dosing
FGF19
Time frame: predose to 48 hour after dosing
CL/F
Time frame: predose to 96 hour 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 7 May 2021.
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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.
Jon Rankin, Doctor principal investigator
Study Principal Investigator
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 Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in Australia.
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 29 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 Australia. 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: Baseline to day 21). 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.