Trials / Completed
CompletedNCT03783377
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
A Phase 1 Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-APOC3 in Adult Healthy Volunteers as Well as in Severely Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Arrowhead Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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 severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARO-APOC3 | single or multiple doses of ARO-APOC3 by subcutaneous (sc) injections |
| DRUG | sterile normal saline (0.9% NaCl) | calculated volume to match active treatment |
Timeline
- Start date
- 2019-03-08
- Primary completion
- 2021-02-11
- Completion
- 2021-02-11
- First posted
- 2018-12-21
- Last updated
- 2025-12-24
Locations
10 sites across 3 countries: Australia, Canada, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03783377. Inclusion in this directory is not an endorsement.