Single Ascending Dose Study of ANX105

NCT05288881 | Completed Phase 1

• 2 other identifiers: ANX105-NHV-012021-005510-33
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Treatment-Emergent Adverse Events

  Up to Week 7

Secondary Outcomes (7)

• Amount of Serum Total Hemolytic Complement (CH50)

  Up to Week 7

• Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum

  Baseline, Week 7

• Amount of C1q in Cerebrospinal fluid (CSF)

  Up to Week 7

• Serum Concentrations of ANX105

  Up to Week 7

• Maximum Observed Serum Concentration (Cmax) of ANX105

  Up to Week 7

Study Arms (2)

ANX105

EXPERIMENTAL

Biological: ANX105

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ANX105 BIOLOGICAL

Participants will receive single-ascending doses of ANX105 administered by IV infusion.

ANX105

Placebo DRUG

Participants will receive matching placebo administered by IV infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Annexon, Inc.: lead

Study Sites (2)

Annexon Investigational Site 02

Groningen, Netherlands

Location

Annexon Investigational Site 01

Leiden, Netherlands

Location

Study Officials

• Olga Bandman, MD

  Annexon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled single ascending dose study.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: February 28, 2022
• Primary Completion: June 19, 2023
• Study Completion: June 19, 2023
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)