NCT05521269
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- ANX1502
- Conditions
- Healthy
- Sponsor
- Annexon, Inc.
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.
Investigators
Eligibility Criteria
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.
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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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.
Arms & Interventions
ANX1502 SAD
Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
Intervention: ANX1502
ANX1502 SAD
Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
Intervention: Placebo
ANX1502 MAD
Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.
Intervention: ANX1502
ANX1502 MAD
Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
Time Frame: Day 1 (after dosing) through Day 29
Secondary Outcomes
- 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 Sites (1)
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