RecruitingPhase 1ACTRN12617000133336

An Adaptive Design Study for the Assessment of the Safety, Tolerability and Pharmacokinetics of RYI-018 after Single Dosing in Healthy Volunteers and Repeat Dosing in Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD)

Sponsor

Bird Rock Bio Inc

Enrollment

84 participants

Start Date

Feb 14, 2017

Study Type

Interventional

Conditions

Non-Alcoholic Fatty Liver Disease

Summary

This study will be conducted as an adaptive design, randomized, parallel group study to evaluate the pharmacokinetics (PK) and safety of single IV doses of RYI-018 in healthy volunteers and repeat IV doses of RYI-018 in subjects with NAFLD. Part A of the study will be conducted as a double-blind, placebo controlled, randomized, single ascending dose study to determine the safety, tolerability, and PK of RYI-018 in healthy volunteers. During Part B of the study, subjects in each cohort shall be randomized to either RYI-018 or placebo. Three (3) cohorts which will include 20 subjects per cohort with 15 subjects randomized to receive active drug administered at weekly intervals and 5 subjects randomized to receive placebo in each cohort at weekly intervals, per the randomization plan. The primary objective of Part A of the study will be to assess the safety and tolerability of single IV ascending doses of RYI-018 when administered to healthy adult volunteers The primary objective of Part B of the study is to evaluate the safety and tolerability of multiple doses of RYI-018 after 4 weeks of dosing in subjects with NAFLD.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called RYI-018 for people with non-alcoholic fatty liver disease (NAFLD) — a condition where too much fat builds up in the liver, often linked to obesity or diabetes. The study first checks the drug's safety in healthy volunteers (Part A) then tests it in NAFLD patients (Part B) over four weeks. It is an early-stage trial focused on safety, tolerability, and how the body processes the drug. You may be eligible if (Part A — healthy volunteers): - You are between 18 and 45 years old with no medical conditions - You have a healthy BMI (18–29.9) - You are a non-smoker for at least 6 months - You are willing to use contraception during the study You may be eligible if (Part B — NAFLD patients): - You are between 18 and 65 years old - You have a BMI between 25 and 40 - You have confirmed fatty liver (at least 10% liver fat on MRI) - You have diabetes or pre-diabetes - Your weight has been stable for at least 3 months You may NOT be eligible if: - You have HIV, hepatitis B, or hepatitis C - You have a history of cancer, seizures, major depression, or stroke - You are pregnant or breastfeeding - You drink alcohol regularly above recommended limits - You have liver cirrhosis or liver failure - You are on weight-loss medications or have had bariatric surgery Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

An Adaptive Design Study for the Assessment of the Safety, Tolerability and Pharmacokinetics of RYI-018 after Single Dosing in Healthy Volunteers and Repeat Dosing in Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD). Part A: A total of 24 patients will be randomized into 3 cohorts. The anticipated dose levels of RYI-018 for Part A of the study will be 0.6 mg/kg (Cohort 1), 1.2 mg/kg (Cohort 2), and 2.5 mg/kg (Cohort 3), administered by intravenous (IV) infusion weekly as single ascending doses. Part A of the study will be conducted in healthy volunteer only . Part B: A total of 60 patients will be randomized into 3 cohorts that will receive three different dosages. The final doses of RYI-018 selected for Part B of the study will be based on the results from Part A. Subjects will be given a total of four (4) IV doses, administered by IV infusion at weekly intervals per the randomization plan. Part B of the study will be conducted in patients with NAFLD only.. The trial will be conducted in accordance with ICHGCP guidelines, and the National Statement. The Bird Rock Bio delegated monitor will contact and visit the site regularly and will be allowed on request to inspect the various records of the trial [case report forms (CRFs) and other pertinent data] provided that subject confidentiality is maintained. It will be the monitor's responsibility to inspect the CRFs at regular intervals throughout the study, to verify adherence to the protocol and the completeness, consistency and accuracy of the data being entered on them. The monitor must verify that the patient received the study drug assigned by the randomisation centre (by reviewing the written confirmation of the randomisation by IxRS). The monitor will have access to laboratory test reports and other subject records needed to verify the entries on the CRF. The investigator will cooperate with the monitor to ensure that any problems detected in the course of these monitoring visits are resolved. Bird Rock Bio delegated monitors and auditors will have direct access to appropriate parts of records relating to subjects participating in this study for the purpose of verifying the data provided to Bird Rock Bio. The site will permit monitoring, audits, Institutional Review Boards/Independent Ethics Committee (IRB/IEC) review and regulatory inspections by providing direct access to the source data and documents.