Dose Study of ANX1502 in Healthy Volunteers

Recruitment & Eligibility

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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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

Study & Design

Arm && Interventions

Group	Intervention	Description
ANX1502 SAD	ANX1502	Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
ANX1502 SAD	Placebo	Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
ANX1502 MAD	ANX1502	Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.
ANX1502 MAD	Placebo	Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Recruitment & Eligibility