NASH - Nonalcoholic SteatohepatitisPhase 1NCT04463017
Ascending Dose Study of HU6 in Healthy Volunteers
A Phase 1 study testing HU6 in people with NASH - Nonalcoholic Steatohepatitis, run by Rivus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- HU6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 1 Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all the following inclusion criteria to be eligible:
- Male or female between 18 and 45 years of age, inclusive, at time of informed consent.
- Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative urine pregnancy test at Screening and admission to Clinical Research Unit, and using, and agree to continue using, an effective method of contraception for at least 4 weeks prior to first study drug administration until 30 days after the last dose of study drug.
- Female subjects of non-childbearing potential must be surgically sterile (e.g., hysterectomy, bilateral tubal ligation, oophorectomy) or post-menopausal (no menses for >1 year with follicle stimulating hormone >40 U/L at Screening)
- Female subjects of childbearing potential must not donate ova during the study and for at least 30 days after the last dose of study drug.
- Male subjects who have not had a vasectomy and/or Subjects who have had a vasectomy but have not had 2 post surgery negative tests for sperm must agree to use an acceptable method of contraception from time of first dose of study drug until 30 days after the last dose of the study drug, and to not donate sperm during the study and for at least 30 days after the last dose of study drug.
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- Healthy per investigator judgment as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations.
- At Screening, abnormalities or deviations outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- On admission to Clinical Research Unit, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and thyroid values must be within the upper limits of the normal range. Subjects with isolated elevation of bilirubin and presumptive Gilbert's syndrome are permissible. All other laboratory test results that are outside the reference range on admission to CRU and judged by the investigator to be not clinically significant may optionally be repeated. Results that continue to be outside the reference range must be judged by the investigator to be not clinically significant and acceptable for study participation.
- Subject must demonstrate clinical euthyroidism as assessed by a thyroid profile utilizing TSH and Free T4 testing at screening.
- Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive. Additional inclusion criteria for the high BMI single dose cohort:
- Body mass index > 30.0 kg/m2, waist circumference > 41"
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
- Willing and able to comply with the requirements of the study protocol.
Who cannot join
- Subjects presenting with any of the following will not qualify for entry into the study:
- Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the investigator. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
- Any surgical or medical condition or history that, in the opinion of the investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or small bowel resections.
- Contraindication to study drug or its excipients and/or history of allergic or anaphylactic reactions.
- Resting heart rate <45 or >100 bpm; blood pressure < 90 or >140 systolic, or <50 or >100 diastolic.
- On screening ECG and by history:
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- A marked baseline prolongation of QT/QTcF interval (e.g., repeated demonstration of a QTc interval > 450 msec for males and >470 msec for females).
- A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Taking any of the following prohibited medications:
- For non-obese cohorts:
- Any prescription medication (with the exception of all hormonal contraceptives and hormone replacement therapies (oral, injectable, transdermal or implanted)) or over the counter multi-vitamin supplement, including products with CBD or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to admission to CRU.
- For obese cohort:
- Limited background prescription medications are permitted to manage complications of obesity, but any drug known to inhibit or induce cytochrome P450 (CYP) enzymes and/or P-glycoprotein including St. John's wort (Hypericum perforatum) within 14 days or 5 half-lives (whichever is longer) prior to admission to CRU, is prohibited. Also prohibited is the use of concomitant medications that prolong the QT/QTc interval identified in the https://crediblemeds.org/ website list category of 'Known Risk'.
- History of significant drug abuse within one year prior to Screening or use of soft drugs (such as marijuana) within 3 months prior to the Screening visit or hard drugs (such as cocaine, phencyclidine [PCP], opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- History of regular alcohol consumption exceeding 14 drinks/week [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months of Screening.
- Positive urine drug or urine alcohol test at Screening or on admission to CRU.
- Current nicotine use or vaping regularly more than 5 cigarettes or the equivalent per week.
- Consumed any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, pomelo juice, star fruit, Seville or Moro (blood) orange products within 6 days before admission to CRU. Vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard), food containing poppy seeds (e.g., muffins, bagels, and cakes) must not be consumed within 24 hours before admission to CRU.
- Positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV1/2) antibody.
- Diabetes reflected by a fasting plasma glucose level of ≥126 mg/dL and a reflex HbA1c of ≥6.5%.
- Participation in another clinical trial at the time of screening or exposure to any investigational agent within 30 days or 5 half-lives prior to admission to CRU, whichever is longer.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Received a tattoo or body piercing (including ear piercings) within 2 months prior to Day 1, and/or significant open wound that may result in risk of infection.
- Having a condition that the investigator believes would interfere with his/her ability to provide written informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk. Subjects with a history of hypo- or hyperthyroidism, peripheral neuropathy, malignant hyperthermia or chronic recurrent rash that is considered clinically significant by the investigator are excluded.
- Must not be claustrophobic or have a history of claustrophobia, or intolerance of closed or small spaces.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prism Clinical Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single Ascending Doses of HU6 in Healthy Volunteers
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
Read the detailed description
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
Up to 74 subjects will be enrolled to allow for replacement subjects, if deemed necessary. Fewer subjects may be enrolled if not all cohorts are utilized due to identification of the MTD in an earlier cohort.
Double-blind dosing will occur in cohorts 1 through 7. In these cohorts, 6 subjects will receive HU6 and 2 will receive matching placebo.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- HU6
- Keywords
- NASH
- 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.
HU6Drug
HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment: HU6 | Active comparator | Planned doses of HU6; N = 74 Receives: Drug: HU6 |
| Placebo Comparator | Placebo comparator | Non-active study drug N = 14 Receives: Drug: HU6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the dose relationship of PK Parameter Cmax
Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for Cmax analyzed
Measured: 3 months
Assess the dose relationship of PK Parameter AUC
Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for AUC analyzed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start12 Aug 2020
- Primary completion30 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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
- Crossover
- Model description
- The study will be conducted in one phase: a single dose, dose escalation phase in up to 7 cohorts
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rivus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, MD, Principal investigator, Prism Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463017
- Sponsor's protocol ID
- RIV-HU6-101
- Status last verified
- May 2021
- First submitted
- 3 Jul 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single Ascending Doses of HU6 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04463017
- Acronym / sponsor ID
- RIV-HU6-101
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- NASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rivus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 9 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 is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
Detailed description
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
Up to 74 subjects will be enrolled to allow for replacement subjects, if deemed necessary. Fewer subjects may be enrolled if not all cohorts are utilized due to identification of the MTD in an earlier cohort.
Double-blind dosing will occur in cohorts 1 through 7. In these cohorts, 6 subjects will receive HU6 and 2 will receive matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be conducted in one phase: a single dose, dose escalation phase in up to 7 cohorts
| Arm | Type | Receives |
|---|---|---|
| Active Treatment: HU6 | Active comparator | Drug: HU6Planned doses of HU6; N = 74 |
| Placebo Comparator | Placebo comparator | Drug: HU6Non-active study drug N = 14 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female between 18 and 45 years of age, inclusive, at time of informed consent.
- Healthy per investigator judgment as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations.
- Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive. Additional inclusion criteria for the high BMI single dose cohort:
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
- Willing and able to comply with the requirements of the study protocol.
Key exclusion criteria (25 listed)
- Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the investigator. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
- Any surgical or medical condition or history that, in the opinion of the investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or small bowel resections.
- Contraindication to study drug or its excipients and/or history of allergic or anaphylactic reactions.
- Resting heart rate <45 or >100 bpm; blood pressure < 90 or >140 systolic, or <50 or >100 diastolic.
- On screening ECG and by history:
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 |
|---|---|---|
| HU6HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH) | Drug | Active Treatment: HU6, Placebo Comparator |
Primary outcome
Assess the dose relationship of PK Parameter Cmax
Time frame: 3 months
Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for Cmax analyzed
Assess the dose relationship of PK Parameter AUC
Time frame: 3 months
Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for AUC analyzed
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 4 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.
Mark Matson, MD principal investigator
Prism Research Clinic
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 HU6 in people with NASH - Nonalcoholic Steatohepatitis, run by Rivus Pharmaceuticals, 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 14 inclusion and 25 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 4 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 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?
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?
Assess the dose relationship of PK Parameter Cmax (time frame: 3 months). The study lists 2 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 4 May 2021.