NCT04213807

A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation

A Randomized, Placebo-controlled, Dose-range Finding Study to Assess the Pharmacokinetic and Pharmacodynamic Parameters, Safety, Tolerability, and Immunogenicity of MAA868 in Patients With Atrial Fibrillation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Anthos Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
BIOLOGICAL	MAA868 Cohort 1	Subcutaneous injection: low dose
BIOLOGICAL	MAA868 Cohort 2	Subcutaneous injection: high dose
BIOLOGICAL	MAA868 Cohort 3	Subcutaneous injection: Dose to be determined.
OTHER	Placebo	Subcutaneous injection: Placebo

Timeline

• Start date: 2019-12-11
• Primary completion: 2020-12-29
• Completion: 2021-03-08
• First posted: 2019-12-30
• Last updated: 2022-01-11
• Results posted: 2021-12-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study