ANX1502 Dose Study Healthy Volunteers Accepted

Description

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

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.

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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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.