NCT04535752

A Single and Multiple Ascending Dose Study of ANX009 in Normal Healthy Volunteers (NHV)

A Phase 1, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneous ANX009 in Normal Healthy Volunteers (NHV)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmakokinetics and pharmacodynamics of single and repeated doses of ANX009

Detailed description

In this first in human, phase 1, randomized, double-blind, placebo-controlled study, single and multiple ascending doses of ANX009 or placebo will be administered to 48 healthy subjects. Single Ascending Dose (SAD): Each SAD subject will participate for approximately 4 weeks (3 nights in-clinic confinement). Multiple Ascending Dose: Each MAD subject will participate for approximately 6 weeks (17 nights in-clinic confinement). All subjects will be contacted (in clinic visit or phone call) 6 months after study completion.

Conditions

• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ANX009	Single or multiple ascending dose
DRUG	Placebo	Single or multiple ascending dose

Timeline

• Start date: 2020-10-30
• Primary completion: 2021-06-26
• Completion: 2021-06-26
• First posted: 2020-09-02
• Last updated: 2021-08-30

Locations

1 site across 1 country: Australia