Non-Alcoholic Steatohepatitis (NASH)Phase 1NCT04481594
A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects
A Phase 1 study testing HPN-01 in people with Non-Alcoholic Steatohepatitis (NASH), run by Hepanova Inc. at 1 site in United States.
Trial summary
This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy 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 Steatohepatitis (NASH)
- What is being tested?
- HPN-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to Jul 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
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 55 years, inclusive;
- Female subjects have a negative pregnancy test result at screening and admission to the study site, and meet one of the following criteria:
- Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
- Surgically sterile for at least 3 months prior to screening by one of the following means:
- Bilateral tubal ligation
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- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
- Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum FSH and estradiol levels at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
- Normal renal function (eGFR > 90 ml/min/1.75 m2) as determined by Investigator following review of clinical laboratory test results;
- Non-smoker and has not been exposed to any products containing nicotine in the last 6 months;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- Willing and able to adhere to study restrictions and to be confined at the clinical research center;
- Male subjects must agree to utilize a highly effective method of contraception (condom plus spermicide) during heterosexual intercourse from clinic admission until 12 weeks following the end of study visit;
- Male subjects with female partners of child-bearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug and must refrain from donating sperm for this same period.
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Known or suspected malignancy;
- Reported history of pancreatitis or gall stones;
- Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
- Family history of long QTc syndrome;
- History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
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- Poor venous access;
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B core (IgG and IgM) and surface antigen (HBsAg), Hepatitis A antibody (IgM), hepatitis C antibody (IgG), or hepatitis E (IgG and IgM) at Screening;
- Donated or lost >500 mL of blood in the previous 3 months prior to screening;
- Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives) prior to first dose of study drug, whichever is longer;
- Taken any prescription medications (with the exception of hormonal contraceptive) within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
- Hospital admission or major surgery within 6 months prior to screening;
- A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
- A history of alcohol abuse according to medical history (≥ 2 drinks per day for male and ≥ 1 drink per day for female) within 9 months prior to screening;
- A positive screen for alcohol, drugs of abuse at screening or admission;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Use of over-the-counter (OTC) medication within 7 days, and/or herbal medications (including St John's Wort, herbal teas, garlic extracts) within 7 days prior to first dose of study drug (Note: Use of acetaminophen at < 2 g/day is permitted until 24 hours prior to dosing);
- Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Frontage Clinical Services, Inc
Secaucus, New Jersey, 07094
Michelle Pluviose, MS, 201-416-7763, mpluviose@frontagelab.com
Annie Li, MD, 2014167770, ali@frontagelab.com
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPN-01
This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects
Read the detailed description
This study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when HPN-01 is orally administered as single doses and as multiple doses to healthy subjects.
The study will be conducted in 2 parts: a single ascending dose (SAD) phase (Part 1) and a multiple ascending dose (MAD) phase (Part 2). One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01.
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Being tested
- HPN-01, Placebo
- 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.
HPN-01Drug
25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 capsules
PlaceboDrug
25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| HPN-01 | Experimental | Part 1: Including 6 dose cohorts (25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg). Each dose cohort will receive a single dose of HPN-01. One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01.
Part 2: Including 3 dose cohorts (50 mg, 100 mg and 200 mg). Each dose cohort will receive HPN-01 once daily for a consecutive 14 days. Receives: Drug: HPN-01 |
| Placebo | Placebo comparator | Part 1: Including 6 dose cohorts (25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg). Each dose cohort will receive a single dose of HPN-01 placebo.
Part 2: Including 3 dose cohorts (50 mg, 100 mg and 200 mg). Each dose cohort will receive HPN-01 placebo once daily for a consecutive 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-dose PK Parameter
Cmax of HPN-01
Measured: Up to 72 hours postdose
Single-dose PK Parameter
AUClast of HPN-01
Measured: Up to 72 hours postdose
Single-dose PK Parameter
AUCinf of HPN-01
Measured: Up to 72 hours postdose
Multiple-dose PK Parameters
Cmax of HPN-01
Measured: Up to 24 hours postdose
Multiple-dose PK Parameters
Ctau of HPN-01
Measured: Up to 24 hours postdose
Multiple-dose PK Parameters
AUCtau of HPN-01
Measured: Up to 24 hours postdose
Incidence of Adverse Events
Measured: Up to 15 days plus 6 days
Proportion of Participants with 12-lead ECG Abnormalities
Measured: Up to 15 days plus 6 days
Proportion of Participants with Clinical Laboratory Abnormalities
Measured: Up to 15 days plus 6 days
Secondary outcomes (2)
Measurement of PD Biomarker Level of Fibroblast Growth Factor 19 (FGF19) Following Oral Single and Multiple Ascending Dose Administration
Measured: Up to 24 hours postdose
Measurement of PD Biomarker Level of C4 Following Oral Single and Multiple Ascending Dose Administration
Measured: Up to 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start8 Sep 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic 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
- Sequential
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hepanova Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481594
- Sponsor's protocol ID
- HPN-01-US-101
- Status last verified
- Feb 2021
- First submitted
- 16 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPN-01
- ClinicalTrials.gov ID
- NCT04481594
- Acronym / sponsor ID
- HPN-01-US-101
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hepanova Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 22 Jul 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.
This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects
Detailed description
This study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when HPN-01 is orally administered as single doses and as multiple doses to healthy subjects.
The study will be conducted in 2 parts: a single ascending dose (SAD) phase (Part 1) and a multiple ascending dose (MAD) phase (Part 2). One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| HPN-01 | Experimental | Drug: HPN-01Part 1: Including 6 dose cohorts (25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg). Each dose cohort will receive a single dose of HPN-01. One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01. Part 2: Including 3 dose cohorts (50 mg, 100 mg and 200 mg). Each dose cohort will receive HPN-01 once daily for a consecutive 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboPart 1: Including 6 dose cohorts (25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg). Each dose cohort will receive a single dose of HPN-01 placebo. Part 2: Including 3 dose cohorts (50 mg, 100 mg and 200 mg). Each dose cohort will receive HPN-01 placebo once daily for a consecutive 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 55 years, inclusive;
- Female subjects have a negative pregnancy test result at screening and admission to the study site, and meet one of the following criteria:
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
- Normal renal function (eGFR > 90 ml/min/1.75 m2) as determined by Investigator following review of clinical laboratory test results;
Key exclusion criteria (18 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Known or suspected malignancy;
- Reported history of pancreatitis or gall stones;
- Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
- Family history of long QTc syndrome;
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 |
|---|---|---|
| HPN-0125 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 capsules | Drug | HPN-01 |
| Placebo25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 placebo capsules | Drug | Placebo |
Primary outcome
Single-dose PK Parameter
Time frame: Up to 72 hours postdose
Cmax of HPN-01
Single-dose PK Parameter
Time frame: Up to 72 hours postdose
AUClast of HPN-01
Single-dose PK Parameter
Time frame: Up to 72 hours postdose
AUCinf of HPN-01
Multiple-dose PK Parameters
Time frame: Up to 24 hours postdose
Cmax of HPN-01
Multiple-dose PK Parameters
Time frame: Up to 24 hours postdose
Ctau of HPN-01
Multiple-dose PK Parameters
Time frame: Up to 24 hours postdose
AUCtau of HPN-01
Incidence of Adverse Events
Time frame: Up to 15 days plus 6 days
Proportion of Participants with 12-lead ECG Abnormalities
Time frame: Up to 15 days plus 6 days
Proportion of Participants with Clinical Laboratory Abnormalities
Time frame: Up to 15 days plus 6 days
2 secondary outcomes
Measurement of PD Biomarker Level of Fibroblast Growth Factor 19 (FGF19) Following Oral Single and Multiple Ascending Dose Administration
Time frame: Up to 24 hours postdose
Measurement of PD Biomarker Level of C4 Following Oral Single and Multiple Ascending Dose Administration
Time frame: Up to 24 hours postdose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
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 HPN-01 in people with Non-Alcoholic Steatohepatitis (NASH), run by Hepanova Inc. at 1 site in United States.
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 19 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 10 Feb 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Pluviose, MS (201-416-7763, mpluviose@frontagelab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-dose PK Parameter (time frame: Up to 72 hours postdose). The study lists 9 primary outcomes in all. 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 10 Feb 2021.