Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03261739




Registration number
NCT03261739
Ethics application status
Date submitted
3/08/2017
Date registered
25/08/2017
Date last updated
14/03/2019

Titles & IDs
Public title
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Scientific title
An Adaptive Design Study for the Assessment of the Safety, Tolerability, and Pharmacokinetics of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Secondary ID [1] 0 0
BRB-018-001-US
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NAFLD 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - RYI-018
Treatment: Other - Placebo

Experimental: RYI- 018 - The doses of RYI-018 to be evaluated in sequential cohorts will be 0.6 mg/kg, 1.2 mg/kg, and 2.5 mg/kg.

Placebo comparator: Placebo - vehicle control


Treatment: Other: RYI-018
Anti-CB1 monoclonal antibody

Treatment: Other: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical evaluation of adverse events
Timepoint [1] 0 0
Continuous through 67 days
Secondary outcome [1] 0 0
Time to peak serum concentration
Timepoint [1] 0 0
Week 1, Week 4
Secondary outcome [2] 0 0
Peak serum concentration
Timepoint [2] 0 0
Week 1, Week 4
Secondary outcome [3] 0 0
Area under the serum concentration versus time curve (AUC)
Timepoint [3] 0 0
Week 1, Week 4
Secondary outcome [4] 0 0
Apparent volume of distribution
Timepoint [4] 0 0
Week 1, Week 4
Secondary outcome [5] 0 0
Immunogenicity as determined by the concentration of serum anti-RYI-018 antibodies.
Timepoint [5] 0 0
Days 8, 15, 22, 29, 36, 67

Eligibility
Key inclusion criteria
Key

1. Adult male or females, 18 to 65 years of age (inclusive) at the time of screening.
2. BMI =25.0 and =40.0 (kg/m2) (inclusive).
3. Liver ultrasound (or transient elastography if approved by medical monitor) which qualitatively shows fatty liver or documented history of NAFLD.
4. Liver fat percentage by MRI of approximately 10% or greater (MRI to be performed only in subjects with documented NAFLD or fatty liver by ultrasound or transient elastography if approved by medical monitor).
5. Type 2 diabetes or prediabetes.
6. Negative urine drug screen/alcohol breath test at screening.
7. Non-smokers as defined by not smoked any tobacco or nicotine-containing products within 3 months prior to screening. No current use of any nicotine containing product.

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Positive serologic testing for HIV, HBsAg, or HCV.
2. Have any known malignancy or history of malignancy, except for basal cell or squamous cell skin cancer that has been treated with no evidence of recurrence for at least 3 months prior to Screening.
3. Have any underlying physical or psychological medical condition that, in the opinion of the Investigator or sponsor, would make it unlikely that the subject will complete the study or is not in the subject's best interest
4. Liver function tests AST or ALT >5 x ULN at screening. One repeat test may be allowed within 7 days at the discretion of the Investigator.
5. Total bilirubin > ULN at screening except in patients with a known history of Gilbert's syndrome.
6. History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
7. Administration of IP in another trial within 30 Days or 5 times the investigational drug half-life, whichever is longer, prior to the first study drug administration.
8. History of cerebrovascular event acute coronary syndrome within 6 months of screening.
9. Any history of seizures, major depression, suicidality, or unexplained syncope.
10. Subjects with other active (acute or chronic) liver disease other than NAFLD/NASH (e.g., autoimmune liver disease, viral hepatitis, genetic hemochromatosis, Wilson disease, alpha-1-antitrypsin deficiency, alcohol liver disease, drug induced liver disease).
11. Use of prescription or non-prescription weight loss medications, thiazolidinediones, investigational or approved medications for NASH, or antidepressant medications within 90 days of screening.
12. Use of insulin injections within 30 days of screening.
13. History of bariatric surgery or plans for bariatric surgery or an attempt to lose weight during study.
14. Daily alcohol intake >20 g/day for women and >30 g/day for men (on average per day), as per medical history.
15. Subjects with renal dysfunction estimated glomerular filtration rate <60 mL/min/1.73 m2.
16. HbA1c >9.5% at screening.
17. Pregnant or breastfeeding women.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/08/2018
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
BRB Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bird Rock Bio, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ProSciento, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Perspectum
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03261739