NCT04419688

A First in Human Study of STT-5058, an Antibody That Binds ApoC3

A Double-blind, Randomised, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple-ascending Doses of Intravenously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Single-ascending and Multiple Doses of Subcutaneously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Patient Volunteers With Hypertriglyceridemia.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Staten Biotechnology BV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A First in Human Study of STT-5058, an Antibody That Binds ApoC3, investigating single and multiple ascending intravenous doses and ascending subcutaneous doses of STT-5058 in otherwise healthy volunteers with elevated triglyceride levels

Detailed description

The study is in five parts. Part A is up to 6 single ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs \>150mg/dL. Part B is up to 4 multiple ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs \>150mg/dL who will receive 3 doses at 2 week intervals. Part C will recruit a single cohort of patient volunteers with TRG \>200mg/dL who will receive 3 doses at 2 week intervals of STT-5058. Part D will investigate up to 2 single ascending doses of subcutaneous STT-5058. Part E will recruit a single cohort of otherwise healthy volunteers with TRG \> 150mg/dL to receive 4 doses subcutaneously of STT-5058 over 4 weeks

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	STT-5058	Monoclonal Antibody STT-5058
DRUG	Placebo	Matching placebo to STT-5058

Timeline

• Start date: 2020-05-26
• Primary completion: 2022-12-23
• Completion: 2022-12-23
• First posted: 2020-06-05
• Last updated: 2023-01-23

Locations

1 site across 1 country: United Kingdom