A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers

Annexon, Inc.2 sites in 1 country23 target enrollmentFebruary 28, 2022

ConditionsHealthy

InterventionsANX105 Placebo

DrugsPlacebo

Overview

Phase: Phase 1
Intervention: ANX105
Conditions: Healthy
Sponsor: Annexon, Inc.
Enrollment: 23
Locations: 2
Primary Endpoint: Number of Participants Who Experienced Treatment-Emergent Adverse Events
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.

Registry

clinicaltrials.gov

Start Date

February 28, 2022

End Date

June 19, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Annexon, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
•Have been fully vaccinated with SARS-CoV-2 vaccination according to local guidelines within 14 days prior to Day -
•Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.

Exclusion Criteria

•Clinically significant infection within 30 days prior to Day -1 that required medical intervention.
•Significant allergies to humanized monoclonal antibodies.
•Use of immunosuppressants including high-dose systemic corticosteroids within 30 days prior to Day -
•Antinuclear antibodies (ANA) titer ≥1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) at Screening.
•Have poor venous access limiting phlebotomy.
•Donation or loss of \> 500 milliliter whole blood within 30 days prior to Day 1 or donation of plasma within 14 days prior to Day -
•Hospitalization during the 4 weeks prior to Screening.

Arms & Interventions

ANX105

Intervention: ANX105

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants Who Experienced Treatment-Emergent Adverse Events

Time Frame: Up to Week 7

Secondary Outcomes

Amount of Serum Total Hemolytic Complement (CH50)(Up to Week 7)
Amount of C1q in Cerebrospinal fluid (CSF)(Up to Week 7)
Maximum Observed Serum Concentration (Cmax) of ANX105(Up to Week 7)
Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum(Baseline, Week 7)
Serum Concentrations of ANX105(Up to Week 7)
Area Under the ANX105 Serum Concentration-Time Curve (AUC)(Up to Week 7)
CSF Concentrations of ANX105(Up to Week 7)