Dose Study of ANX1502 in Healthy Volunteers

NCT05521269 | Completed Phase 1

• 2 other identifiers: ANX1502-NHV-012022-000594-21
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502

  Day 1 (after dosing) through Day 29

Secondary Outcomes (5)

• Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502

  Predose up Day 29

• Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502

  Predose up Day 29

• Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose 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 and Multiple Doses of ANX1502

  Predose up Day 29

• Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502

  Predose up to Day 29

Study Arms (2)

ANX1502 SAD

EXPERIMENTAL

Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.

Drug: ANX1502; Drug: Placebo

ANX1502 MAD

EXPERIMENTAL

Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.

Drug: ANX1502; Drug: Placebo

Interventions

ANX1502 DRUG

ANX1502 is a prodrug of ANX1439.

ANX1502 MAD; ANX1502 SAD

Placebo DRUG

Placebo comparator.

ANX1502 MAD; ANX1502 SAD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• MAD cohorts only: Documented history of vaccinations within 5 years of Screening or willing to undergo vaccinations prior to Screening against encapsulated bacterial pathogens.

You may not qualify if:

• 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 study drug administration 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.

Sponsors & Collaborators

• Annexon, Inc.: lead

Study Sites (1)

Annexon Investigational Site 01

Groningen, Netherlands

Location

Study Officials

• Olga Bandman

  Annexon, Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 30, 2022
• Study Start: June 27, 2022
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

NL (1)