Dose Study of ANX1502 in Healthy Volunteers

Annexon

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: ANX1502

Study type: Interventional

Funder types: Industry

Identifiers

NCT05521269

2022-000594-21 (EudraCT Number)

ANX1502-NHV-01

Details and patient eligibility

About

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

Enrollment: 135 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.
• MAD cohorts only: Documented history of vaccinations within 5 years of Screening 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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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135 participants in 2 patient groups

ANX1502 SAD

Experimental group

Description:

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

Treatment:

Drug: ANX1502

Drug: Placebo

ANX1502 MAD

Experimental group

Description:

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

Treatment:

Drug: ANX1502

Drug: Placebo