Status:
COMPLETED
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Bird Rock Bio, Inc.
Collaborating Sponsors:
ProSciento, Inc.
Perspectum
Conditions:
NAFLD
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.
Detailed Description
BRB-018-001 will be conducted as a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD. Sub...
Eligibility Criteria
Inclusion
- Key
- Adult male or females, 18 to 65 years of age (inclusive) at the time of screening.
- BMI ≥25.0 and ≤40.0 (kg/m2) (inclusive).
- Liver ultrasound (or transient elastography if approved by medical monitor) which qualitatively shows fatty liver or documented history of NAFLD.
- 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).
- Type 2 diabetes or prediabetes.
- Negative urine drug screen/alcohol breath test at screening.
- 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
Exclusion
- Positive serologic testing for HIV, HBsAg, or HCV.
- 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.
- 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
- 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.
- Total bilirubin \> ULN at screening except in patients with a known history of Gilbert's syndrome.
- History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- 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.
- History of cerebrovascular event acute coronary syndrome within 6 months of screening.
- Any history of seizures, major depression, suicidality, or unexplained syncope.
- 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).
- Use of prescription or non-prescription weight loss medications, thiazolidinediones, investigational or approved medications for NASH, or antidepressant medications within 90 days of screening.
- Use of insulin injections within 30 days of screening.
- History of bariatric surgery or plans for bariatric surgery or an attempt to lose weight during study.
- Daily alcohol intake \>20 g/day for women and \>30 g/day for men (on average per day), as per medical history.
- Subjects with renal dysfunction estimated glomerular filtration rate \<60 mL/min/1.73 m2.
- HbA1c \>9.5% at screening.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03261739
Start Date
August 28 2017
End Date
August 24 2018
Last Update
March 14 2019
Active Locations (6)
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1
BRB Site
Chula Vista, California, United States, 91911
2
BRB Site
Miami, Florida, United States, 33147
3
BRB Site
Orlando, Florida, United States, 32804
4
BRB Site
San Antonio, Texas, United States, 78215