Dose Study of ANX1502 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX1502 in Normal Healthy Volunteer

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: ANX1502; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 1-650-822-5500; Email: clinicaltrials@annexonbio.com

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • Annexon Investigational Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laboratory tests.
• Documented history of vaccinations within 5 years from enrollment or willing to undergo vaccinations prior to screening against encapsulated bacterial pathogens.

Key Exclusion Criteria:

• History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, malabsorption syndrome, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data. Exceptions can be made for individuals with childhood or remote disorders that are no longer active.
• History of any autoimmune disease
• History of meningitis or septicemia
• Clinically significant infection within 30 days prior to Day -1 that required medical intervention.
• Known genetic deficiencies of the complement cascade system or immunodeficiency.
• Clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
• Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions .
• History of prior other malignancy that could affect compliance with the protocol or interpretation of results
• Has clinically significant laboratory abnormalities or abnormal ECG
• History of splenectomy.
• Antinuclear antibodies titer ≥1:160 at Screening.
• Has donated blood or plasma within 30 days prior to Screening or had a loss of whole blood of more than 500 milliliter (mL) within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANX1502 SAD; Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.	Drug: ANX1502; ANX1502 is a prodrug of ANX1439.; Drug: Placebo; Placebo comparator.
Experimental: ANX1502 with Food; Participants will be administrated a single oral dose of ANX1502 or matching placebo with food.	Drug: ANX1502; ANX1502 is a prodrug of ANX1439.; Drug: Placebo; Placebo comparator.
Experimental: ANX1502 MAD; Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.	Drug: ANX1502; ANX1502 is a prodrug of ANX1439.; Drug: Placebo; Placebo comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose (With or Without Food) and Multiple Doses of ANX1502	Day 1 (after dosing) through Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma ANX1502 and ANX1439 Concentrations After A Single Dose (With or Without Food) and Multiple Doses of ANX1502	Predose up Day 29
Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502	Predose up Day 29
Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502	Predose up to Day 29
Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502	Predose up Day 29
Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502	Predose up to Day 29

Collaborators and Investigators

• Sponsor: Annexon, Inc.
• Investigators: Study Director: Olga Bandman, Annexon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: August 28, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: healthy
• Other Study ID Numbers: ANX1502-NHV-01; 2022-000594-21 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No