Single Ascending Dose Study of ANX105

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Biological: ANX105

• Registration Number: NCT05288881
• Lead Sponsor: Annexon, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-28
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-21
• Primary Completion: 2023-06-19
• Study Completion: 2023-06-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 -1.
• Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.

Key

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 -1.
• 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 -1.
• Hospitalization during the 4 weeks prior to Screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ANX105	ANX105	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Treatment-Emergent Adverse Events	Up to Week 7

Secondary Outcome Measures

Name	Time	Method
Amount of Serum Total Hemolytic Complement (CH50)	Up to Week 7	Blood samples will be obtained to determine the amount of CH50.
Amount of C1q in Cerebrospinal fluid (CSF)	Up to Week 7	CSF samples will be obtained to determine the amount of C1q.
Maximum Observed Serum Concentration (Cmax) of ANX105	Up to Week 7	Blood samples will be obtained to determine the Cmax of ANX105.
Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum	Baseline, Week 7	Blood samples will be obtained to determine the amount of C1q.
Serum Concentrations of ANX105	Up to Week 7	Blood samples will be obtained to determine serum concentrations of ANX105.
Area Under the ANX105 Serum Concentration-Time Curve (AUC)	Up to Week 7	Blood samples will be obtained to determine the AUC of ANX105.
CSF Concentrations of ANX105	Up to Week 7	CSF samples will be obtained to determine CSF concentrations of ANX105.

Trial Locations

Locations (2)

Annexon Investigational Site 02; 🇳🇱 Groningen, Netherlands

Annexon Investigational Site 01; 🇳🇱 Leiden, Netherlands