Phase
Condition
Familial Chylomicronemia Syndrome
Hypertriglyceridemia
Treatment
RN0361
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Phase I:
Inclusion Criteria:
Willing to provide written informed consent before any study-specific procedures.
Comply with the study requirements and restrictions as listed in the InformedConsent Form and the protocol.
Fasting serum triglyceride levels > 80 mg/dL and fasting LDL-C ≥70 mg/dL atscreening
Female participants must either be nonchildbearing or, if of childbearing potential,not pregnant, not breastfeeding, and using effective contraception. Maleparticipants must use condoms and ensure their partners use contraception if theyare of childbearing potential.
Participants must avoid sperm or egg donation during the study
Exclusion
Exclusion Criteria:
History or presence of any serious or uncontrolled disease
clinically significant health concerns
Recent vaccination with live vaccines, except for influenza, or plans to receivesuch during the study.
Positive tests for alcohol or drugs of abuse at screening.
History of multiple drug allergies or allergic reactions to specific components usedin the study.
Phase II:
Inclusion Criteria:
Willing to provide written informed consent before any study-specific procedures.
Comply with the study requirements and restrictions as listed in the InformedConsent Form and the protocol.
Fasting serum triglyceride levels ≥ 300 mg/dL at screening
Female participants must either be nonchildbearing or, if of childbearing potential,not pregnant, not breastfeeding, and using effective contraception. Maleparticipants must use condoms and ensure their partners use contraception if theyare of childbearing potential.
Exclusion Criteria:
History or presence of any serious or uncontrolled disease
Active pancreatitis within 12 weeks prior to Day 1
Uncontrolled hypertension (sitting blood pressure) >160/100 mm Hg
Uncontrolled diabetes
Symptomatic heart failure (NYHA II-IV)
Positive serologic test of HBV, HCV, or HIV
Alcohol or drugs abuse
History of multiple drug allergies or history of allergic reaction to anoligonucleotide or GalNAc.
History of intolerance to SC injection or relevant abdominal scarring (surgical,burns, etc)
History of malignancy within the last 2 years prior to the date of consent
Note: Additional inclusion/exclusion ceiteria may apply, per protocol.
Study Design
Connect with a study center
University of the Sunshine Coast Clinical Trials
Morayfield, Queensland
AustraliaSite Not Available
University of the Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland 4556
AustraliaSite Not Available
Altona Clinical Research
Altona N., Victoria 3025
AustraliaSite Not Available
Nucleus Network Melbourne
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Lifeline Primary Care/Avacare
Lilburn, Georgia 30047
United StatesSite Not Available
Versailles Family Medicine / Avacare
Versailles, Kentucky 40383
United StatesSite Not Available
Axis Clinicals USA
Dilworth, Minnesota 56529
United StatesSite Not Available
Tranquil
Webster, Texas 77598
United StatesSite Not Available
Ogden Clinic, Mountain View / Avacare
Pleasant View, Utah 84404
United StatesSite Not Available
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