Status:
COMPLETED
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Hypertriglyceridemia
Familial Chylomicronemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with sev...
Eligibility Criteria
Inclusion
- Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
- Willing to provide written informed consent and to comply with study requirements
- Normal electrocardiogram (ECG) at screening
- Hypertriglyceridemic patients must have a history of fasting serum triglycerides of at least 300 mg/dL (3.38 mmol/L) at screening or verifiable diagnosis of FCS
Exclusion
- Clinically significant health concerns
- Regular use of alcohol within one month prior to Screening
- Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
- Recent use of illicit drugs
- Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)
- Note: additional inclusion/exclusion criteria may apply, per protocol
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03783377
Start Date
March 8 2019
End Date
February 11 2021
Last Update
December 24 2025
Active Locations (10)
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1
Research Site 2
Camperdown, New South Wales, Australia, 2050
2
Research Site 5
Sippy Downs, Queensland, Australia
3
Research Site 3
Adelaide, South Australia, Australia, 5000
4
Research Site 4
Perth, Washington, Australia, 6009