NCT04031742

A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia

Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

Detailed description

This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.

Conditions

• Homozygous Familial Hypercholesterolemia

Interventions

Type	Name	Description
BIOLOGICAL	IBI306	Administered by subcutaneous injection
BIOLOGICAL	IBI306	Administered by subcutaneous injection

Timeline

• Start date: 2019-09-29
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2019-07-24
• Last updated: 2023-08-09

Locations

1 site across 1 country: China