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

NCT04213807 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-01-11

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Anthos Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Norman E Lepor, MD FACC FAHA FSCAI · Westside Medical Associates of Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2020-12-29
Completion
2021-03-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04213807 on ClinicalTrials.gov