Healthy
Conditions
Keywords
healthy
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.
Interventions
DRUGANX1502
ANX1502 is a prodrug of ANX1439.
DRUGPlacebo
Placebo comparator.
Sponsors
Annexon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed