Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000023550
Ethics application status
Approved
Date submitted
21/11/2023
Date registered
11/01/2024
Date last updated
8/03/2024
Date data sharing statement initially provided
11/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A first in human study to Evaluate the Safety and Tolerability of OLX75016 for treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis.
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety and Tolerability of OLX75016 in Healthy Volunteers.
Secondary ID [1] 310864 0
OLX75016-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
(NAFLD) to steatohepatitis (NASH) 331904 0
fibrosis 332363 0
Cirrhosis 332364 0
Condition category
Condition code
Oral and Gastrointestinal 328635 328635 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
OLX75016 is a chemically synthesized double stranded siRNA targeting expression of the Mitochondrial Amidoxime Reducing Component 1 (MARC1) enzyme for the treatment of nonalcoholic fatty liver disease (NAFLD) with liver fibrosis. OLX75016, which is administered by subcutaneous (SC) injection, has been designed to specifically target liver hepatocytes and chemically modified to increase stability.
OLX75016 and a matching placebo will be administered as SC injections in the abdominal region. This study will be conducted in two parts: Part A (SAD) and Part B (MAD).
Part A- Single Ascending Dose (SAD):
Healthy volunteers will be enrolled and randomized to 5 cohorts with each cohort having 8 participants to receive single ascending doses of OLX75016 or placebo (ratio 3:1 active: placebo). The starting dose will be 10 mg, with 5 dose levels planned 10mg, 30mg, 90 mg, 200mg and 450mg. At the discretion of the study Sponsor, in consultation with the safety review committee (SRC), additional cohorts may be added to evaluate intermediate dose levels. Healthy volunteers will be screened between Day -28 to Day -2. Eligible participants will be admitted to the clinic on Day -1. Following confirmation of eligibility, participants will be randomized to receive OLX75016 or a placebo before dose administration on Day 1. Doses will be administered in the clinic, under the supervision of site staff. All participants will be confined to the clinic until the completion of all safety/tolerability and PK assessments on Day 3. 2 Sentinel participants will be dosed in the SAD Cohorts. 1 Sentinel will be allocated to placebo, and 1 to active treatment via Randomisation list instruction. The Randomisation list will be prepared by the Avance unblinded Biostatistician. Dosing in each cohort will start with two sentinel participants with one of the two sentinels randomized to receive OLX75016 and the other randomized to receive placebo. The safety and tolerability of each sentinel participant will be monitored in the clinic until Day 3. Following completion of Day 3 assessments for sentinel participants, all available safety/tolerability information (including Day 3 clinical blood and urine safety laboratory results), will be reviewed by the PI, prior to making the decision to dose the remaining participants in each cohort. Participants will be required to return to the clinic for additional outpatient safety/tolerability assessments on Day 4, 7, 14, 28 and 42. Participants will be discharged from each visit following completion of all safety and PK assessments, the end of study (EoS) visit will be on Day 56. Compliance will be monitored by site staff witnessing of dosing and will be documented in participant study files. If participants experience any clinically significant (CS) AEs during the confinement period, they may remain in the clinical facility for further observation at the discretion of the Principal Investigator (PI). After at least 6 out of 8 participants have completed the Day 28 visit, the SRC will review all available safety/tolerability data (including safety/tolerability data collected on Day 28), discuss the findings, and decide to:
• Enrol the next dose cohort in Part A at the protocol-defined dose level.
• Enrol the next dose cohort at an intermediate dose level not defined in the protocol; or
• Terminate enrolment in Part A of the study.
In conjunction with the above, following completion of SAD Cohort 3, the SRC may also determine a starting dose level for Part B (MAD) and determine whether sentinel dosing should be used for the first cohort in Part B (MAD). If the SRC determines sentinel dosing is required, the SRC will advise on the minimum length of time for participants to be followed prior to dosing the remaining participants in the cohort.
Part B- Multiple Ascending Dose (MAD):
Part B (MAD) may commence following the completion of SAD Cohort 3. Upto 30 participants will be enrolled over 3 dose escalation cohorts in Part B of the study. Part A and B will not be the same group of participants. New recruitment would occur for Part B , MAD dosing. Part B will see 10 participants dosed , where 2 will be allocated to placebo treatment and 8 to the active Investigational Product, as per Randomisation list. Randomisation list will be prepared by the Avance Biostatistician. The starting dose for MAD will be based on emerging results from Part A (SAD), to be confirmed by the SRC, prior to dosing of MAD Cohort 1. Up to 3 dose levels (low, medium and high) are planned to be evaluated. At the discretion of the study Sponsor, in consultation with the SRC additional cohorts may be added in order to evaluate intermediate dose levels, based on the results of the SAD part of the study. Cohorts will be dosed in escalating order, with participants in each cohort randomized to receive OLX75016 or placebo at a ratio of 4:1 (active: placebo). Following confirmation of eligibility, participants will be confined to the unit on Day -1 until Day 3. Participants will be randomized to receive OLX75016 or placebo prior to first dose administration (Day 1) and will be discharged following completion of all safety and PK assessments on Day 3. Doses will be administered subcutaneously in the clinic, under the supervision of site staff. Participants will be required to attend the clinic on Days 4, 7, and 14 for safety and tolerability assessments. Participants will return to the clinic for a second confinement period from Day 28 to Day 31, with the second dose of OLX75016 or placebo administered on Day 29. Participants will be required to attend the clinic on Days 32, 35, 42, 56, and 84 for safety and tolerability assessments before the End of Study visit on Day 112. Sentinel dosing will not be required for MAD unless recommended by the SRC based on findings from Part A (SAD). Compliance will be monitored by site staff witnessing of dosing and will be documented in participant study files. If participants experience any clinically significant (CS) AEs during the confinement period, they may remain in the clinical facility for further observation at the discretion of the Principal Investigator (PI). After at least 8 out of 10 participants have completed the Day 56 visit, the SRC will review all available safety/tolerability data (including safety/tolerability data collected on Day 56) and available PK data, discuss the findings, and decide to:
• Enrol the next dose cohort in Part B at the protocol-defined dose level.
• Enrol the next dose cohort at an intermediate dose level not defined in the protocol; or
• Terminate enrolment in Part B of the study.
In conjunction with the above, the SRC may also determine whether sentinel dosing should be employed in subsequent cohorts in Part B. If the SRC determines sentinel dosing is required, the SRC will advise on the minimum length of time for participants to be followed prior to dosing the remaining participants in the cohort.
Intervention code [1] 327349 0
Treatment: Drugs
Comparator / control treatment
The placebo will be the Normal saline (0.9% NaCl) identical in appearance to IP. Placebo will be administered as Subcutaneous injection.
Control group
Placebo

Outcomes
Primary outcome [1] 336530 0
To evaluate the safety and tolerability of single and multiple ascending doses of OLX75016 in healthy volunteers (Composite Primary Outcome).
Timepoint [1] 336530 0
Part A (SAD) -
• Local tolerability - site of subcutaneous injections- On Day 1, local tolerability assessments will be performed at 0.25, 0.5 and 1 hour post-dose. All other local tolerability assessments will be performed at any time on the Days 2, 3, 4 and 7.
• Clinical laboratory results - haematology, serum chemistry, urinalysis- Safety blood samples and Urnilaysis are collected at the time points - screening visit, Day -1,, Days 1, 2, 7, 28, 42 and Day 56 (End of Study Visit (EoS).
• Vital signs- Vital Signs are perfomed at Screening visit, Day -1, Days 1, 2, 3, 4, 7, 14, 28, 42 and Day 56 (EoS).
• Twelve-lead ECGs - All ECGs will be performed in triplicate. Twelve-lead ECGs are perfomed at Screening visit, Day -1, Days 1, 2, 3, 4, 7, 14, 28, 42 and Day 56 (EoS). Continuous 12-lead telemetry monitoring will be conducted from at least 1 hour pre-dose to at least 24 hours post-dose.
• Evaluation of Inflammatory Markers - Blood samples are collected at Screening visit, Days 1, 2, 7 and 56 (EoS).
• Evaluation of Metabolic Panel - Blood samples are collected at Screening visit, Day -1, Days 1, 2, 7, 28 and 56 (EoS).

Part B (MAD)-
• Local tolerability - site of subcutaneous injections- On Day 1 and Day 29 local tolerability assessments will be performed at 0.25, 0.5 and 1 hour post-dose. All other local tolerability assessments will be performed at any time on days 2, 3, 4, 7, 30, 31, 32, 35 and EOS/Early Termination.
• Clinical laboratory results - haematology, serum chemistry, urinalysis- Safety blood samples and Urnilaysis are collected at the time points - screening visit, Day -1,, Days 1, 2, 28, 29, 31, 42, 56, 84 and Day 112 (End of Study Visit (EoS).
• Vital signs- Vital Signs are perfomed at Screening visit, Day -1, Days 1, 2, 3, 4, 7, 14, 28, 29, 30, 31, 32, 35, 42, 56, 84 and Day 112 (EoS).
• Twelve-lead ECGs - All ECGs will be performed in triplicate. Twelve-lead ECGs are perfomed at Screening visit, Day -1, Days 1, 2, 3, 4, 7, 29, 30, 31, 32, 35, 42, 56, 84 and 112. Continuous 12-lead telemetry monitoring will be conducted from at least 1 hour pre-dose to at least 24 hours post-dose. Also, telemetry will be performed on Day 29.
• Evaluation of Inflammatory Markers - Blood samples are collected at Screening visit, Days 1, 2, 7, 29, 30, 35, 56 and 112 (EoS).
• Evaluation of Metabolic Panel - Blood samples are collected at Screening visit, Day -1, Days 1, 2, 7, 29, 30, 35, 56, 84 and 112 (EoS).
Secondary outcome [1] 428698 0
To evaluate the pharmacokinetics (PK) of OLX75016 in plasma and urine following single and multiple dose administration in healthy volunteers.
Timepoint [1] 428698 0
Part A (SAD)
PK Timepoints include - Day 1- predose, 30 mins post dose, 1 hour post dose, 2hour post dose, 4 hour post dose, 8 hour post dose,
Day 2- 24 hour post dose
Day 3- 48 hour post dose

Urine samples timepoints include:
Day 1- Between 0-2 hour , 2-4 hour, 4-8 hours, 8-2 hours post dose.

Part B (MAD)
PK timepoints include:
Day 1- predose, 30 mins post dose, 1 hour post dose, 2hour post dose, 4 hour post dose, 8 hour post dose,
Day 2- 24 hour post dose
Day 3- 48 hour post dose
Day 29- predose, 1 hour post dose, 2hour post dose, 4 hour post dose, 8 hour post dose,
Day 30- 24 hour post dose
Day 31- 48 hour post dose

Urine samples timepoints include:
Day 1 and Day 29 - Between 0-2 hour , 2-4 hour, 4-8 hours, 8-24 hours post dose.
Secondary outcome [2] 428699 0
To evaluate the immunogenicity of OLX75016 following single and multiple dose administration in healthy volunteers
Timepoint [2] 428699 0
Blood samples are collected at the following timepoints.
Part A- Immunogenecity - Screening visit, Day 1, Day 2, Day 7 and Day 56 (EoS)
Cytokines - Day 1, Day 2, Day 28.

Part B - Immunogenecity - Screening visit, Day 1, Day 2, Day 7, Day 29, Day 30, Day 35, Day 56 and Day 112 (EoS).
Cytokines - Day 1, Day 2, Day 28, Day 29, Day 30, Day 35 and Day 56.

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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 therapy.
19. Suspicion of or known Gilbert’s syndrome.
20. Weight loss of more than 10% within the last 3 months prior to screening.
21. Has donated blood or blood products within 3 months prior to first dose administration.
22. Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds).
23. History of major bleed or high-risk of bleeding diathesis.
24. Use of anabolic steroids and systemic treatment with glucocorticosteroids within 3 months prior to the Screening Visit.
25. Presence or evidence of recent sunburn, scar tissue, tattoo, open sore or branding that, in the opinion of the PI or medically qualified designee, would interfere with the interpretation of skin adverse reactions at the injection site.
26. Any other condition or prior therapy that in the opinion of the PI (or designee) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All study participants who sign an informed consent form at screening will receive a unique screening number. Participants who meet the study eligibility criteria will be assigned a randomization number prior to first dose administration on Day 1 by the unblinded pharmacy personnel as per site standard process, which corresponds to a study treatment (OLX75016 or placebo). The allocation to OLX75016 or placebo will be performed using a block randomization algorithm. and will be documented in the study randomization schedule. Dosing in each SAD Cohort is planned to start with two sentinel participants, with one of the two sentinels randomized to receive OLX75016 and other randomized to receive placebo. Sentinel dosing is not planned for cohorts in Part B. For Part B (MAD), participants will be randomized in blocks of 5 to ensure a minimum of 2 participants allocated to placebo in the case that less than 10 participants are enrolled and dosed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Detailed methodology for the summation and statistical analysis of the data collected will be documented in a Statistical Analysis Plan. Summaries will be presented separately for Part A (SAD) and Part B (MAD), by dose level within study part and overall within study part. For descriptive statistics, continuous data will be summarized by dose level and time point using the number of observations, arithmetic mean, standard deviation (SD), median, minimum and maximum. Discrete data will be summarized using counts and percentages. All available data will be included in data listings. Data tabulations will be performed for specific analysis populations.
Intent to Treat Analysis Set
The Intent to Treat (ITT) analysis set will include all randomized participants who receive at least one dose of study drug (OLX75016 or Placebo). Participants will be analyzed according to treatment randomization.
Safety Analysis Set
All participants who receive at least one dose of study drug will be included in the Safety Analysis Set and will be analyzed as per the actual treatment received, if this differs from that to which the participant was randomized.
Pharmacokinetic Analysis Set
The PK Analysis Set will include all participants in the Safety Analysis Set who have no major protocol violations that impact on pharmacokinetics and sufficient data to reliably derive at least one PK parameter

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/02/2024
Actual
13/02/2024
Date of last participant enrolment
Anticipated
15/10/2024
Actual
Date of last data collection
Anticipated
3/03/2025
Actual
Sample size
Target
70
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25814 0
Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
Recruitment postcode(s) [1] 41642 0
4007 - Herston

Funding & Sponsors
Funding source category [1] 315124 0
Commercial sector/Industry
Name [1] 315124 0
OliX Pharmaceuticals
Country [1] 315124 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
OliX AU Pty Ltd
Address
Suite 402/15 Blue Street, North Sydney, NSW 2060 Australia
Country
Australia
Secondary sponsor category [1] 317138 0
Commercial sector/Industry
Name [1] 317138 0
Avance Clinical Pty Ltd
Address [1] 317138 0
213 Glynburn Road, Firle, South Australia 5070
Country [1] 317138 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314060 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314060 0
55 commercial road, melbourne VIC 3004
Ethics committee country [1] 314060 0
Australia
Date submitted for ethics approval [1] 314060 0
13/11/2023
Approval date [1] 314060 0
20/12/2023
Ethics approval number [1] 314060 0

Summary
Brief summary
OLX75016 is being developed by OliX Pharmaceuticals as a treatment for patients with treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis. This study will evaluate the safety and tolerability of single and multiple ascending doses of OLX75016 in healthy volunteers. This study will be conducted in 2 parts : Part A (Single asecending dose) and Part B (Multiple ascending dose). Upto 70 Participants are expected to be engaged with the study for upto 87 days in Part A or upto 143 days in Part B of the study. OLX75016 and matching placebo will be administered as SC injections in the abdominal region in this study.
Part A- Following confirmation of eligibility, participants will be randomized to receive OLX75016 or placebo prior to dose administration on Day 1. All participants will be confined to the clinic until the completion of all safety/tolerability and PK assessments on Day 3. Participants will be required to return to the clinic for additional outpatient safety/tolerability assessments on Day 4, 7, 14, 28 and 42. Participants will be discharged from each visit following completion of all safety and PK assessments, the end of study (EoS) visit will be on Day 56
Part B - Following confirmation of eligibility, participants will be confined to the unit on Day -1 until Day 3. Participants will be randomized to receive OLX75016 or placebo prior to first dose administration (Day 1) and will be discharged following completion of all safety and PK assessments on Day 3. Participants will be required to attend the clinic on Days 4, 7 and 14 for safety and tolerability assessments.
Participants will return to the clinic for a second confinement period from Day 28 to Day 31, with the second dose of OLX75016 or placebo administered on Day 29. Participants will be required to attend the clinic on Days 32, 35, 42, 56 and 84 for safety and tolerability assessments before the EoS visit on Day 112.

It is hoped that the information learned from this study will help the sponsor learn more about how best to treat patients suffering from NASH and liver fibrosis in future. This research may also give rise to new or improved improvements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130270 0
Mr Dr Richard Friend
Address 130270 0
Nucleus Network Brisbane, Level 5 Clive Berghofer Cancer Research Centre, 300C Herston Road, Herston, Queensland, 4006
Country 130270 0
Australia
Phone 130270 0
+61 37072720
Fax 130270 0
Email 130270 0
[email protected]
Contact person for public queries
Name 130271 0
Mr Nucleus Network Brisbane
Address 130271 0
Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, Queensland 4006
Country 130271 0
Australia
Phone 130271 0
+61 1800 243 733
Fax 130271 0
Email 130271 0
[email protected]
Contact person for scientific queries
Name 130272 0
Mr June Hyun Park
Address 130272 0
OliX Pharmaceuticals, Ace Gwanggyo Tower 1, Suite 1008. 17 Daehak 4-ro, Yeongtong- gu, Suwon-si, Gyeonggi-do, 16226
Country 130272 0
Korea, Republic Of
Phone 130272 0
+82 10 3618 7891
Fax 130272 0
Email 130272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy and Intellectual property considerations


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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