A first in human study to Evaluate the Safety and Tolerability of OLX75016 for treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Conditions
- (NAFLD) to steatohepatitis (NASH)fibrosisCirrhosisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12624000023550
- Lead Sponsor
- OliX AU Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
1.Capable of providing written Informed consent.
2.Healthy male or female, aged between 18 and 65 years, inclusive at screening.
3.Liver fat content less than 6% as determined by MRI-PDFF. Negative cirrhosis screen, human immunodeficiency virus, viral hepatitis B and C serology, autoimmune hepatitis (Liver Kidney Microsomal Liver [LKM] Antibody), transferrin saturation < 45%, at Screening.
4.On a stable diet for at least 4 weeks prior to Day -1, with no plans to significantly alter lifestyle for the duration of the study.
5.Stable health status, as established by physical examination and medical history.
6.Participant is willing to refrain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas), for:
7.Participants must have received at least 3 doses of a Therapeutic Goods Association approved COVID-19 vaccine, with the most recent dose administered > 1 week prior to administration of study drug.
8.Female participants must be of non-childbearing potential i.e., surgically sterilised or post-menopausal or, if of childbearing potential:
a.Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1.
b.Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days
c.If not exclusively in a same-sex relationship, must agree to use adequate contraception
d.If in a same-sex relationship, no form of contraception is required.
11.Male participants must:
a.Agree not to donate sperm from the time of signing consent until at least 90 days after the last dose of study drug.
b.If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception
c.If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom.
1.Has any clinical safety laboratory result considered clinically significant by the Investigator (or designee).
2.In the opinion of the PI (or designee), has evidence of other forms of known chronic liver disease.
3.Use of an investigational agent or device within 30 days or 5 half-lives of Day 1 drug administration in this trial, whichever is longer prior to dosing or current participation in an investigational study.
4.In the opinion of the PI (or designee), has any uncontrolled or serious disease, medical or surgical condition that may interfere with participation or data interpretation.
5.Participant smokes greater than 5 cigarettes per week and/or is unwilling to refrain from smoking (and use of any tobacco products or nicotine-containing products) whilst confined to the clinical unit.
6.History of substance dependence (within the last 12 months) or positive urine drug screen at screening or excessive alcohol consumption during screening.
7.Use of any prescription medication or concomitant medications within 14 days prior to the first dose of study drug, or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, occasional paracetamol (up to a maximum of 2 grams per day). Use of St. John’s Wort (hypericin) may not have been taken within 30 days prior to first dose of study drug.
8.Use of any vaccinations within 14 days prior to the first study drug administration (vaccination for Covid-19 is permitted with the most recent dose administered greater than 1 week prior to first study drug administration).
9.In the opinion of the PI (or designee), has an aversion to, or has history of site reactions to Subcutaneous administrations that would make them unsuitable for inclusion in this trial.
10.Has contraindications to MRI (e.g., metal implants [excluding Titanium]; severe claustrophobia and inability to lie flat for 1 hour).
11.Has international normalized ratio (INR) greater than 1.3.
12.Has platelet count less than 140x10^9/L.
13.Has transferrin saturation greater than 45%.
14.Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
15.Participants with history or pre-existing renal disease, as defined below:
a.estimated glomerular filtration rate less than 60 mL/min/1.73 m^2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) or
b.urinary albumin-to-creatinine ratio greater than 10 mg/µmol (100 mg/g).
16.Relevant history (in the opinion of the PI or designee) of cardiac arrythmias including long QT syndrome, sudden cardiac death, or Torsades de Pointes and/or syncope and/or clinically significant cardiovascular event within the last 6 months prior to the Screening Visit.
17.Participants with a positive SARS-CoV-2 infection (polymerase chain reaction [PCR] or rapid antigen test [RAT] as deemed appropriate by the site’s SOPs or PI discretion) at Screening or Day -1 Visit.
18.Participants with a significant Coronavirus disease 2019 (COVID-19) illness within 6 months of enrolment, defined by one of the following:
c.Participants with a diagnosis of COVID-19 pneumonia based on radiological assessment.
d.Participants with diagnosis of COVID-19 with significant findings from pulmonary imaging tests.
e.Participants with a diagnosis of COVID-19 requiring hospitalization and/or oxygen supplementation th
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method