antibody-mediated autoimmune indications
Conditions
Interventions
ANX1502 or matching placebo
Sponsors
Annexon Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Participants who are 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), single 12-lead ECG and laboratory tests. - [MAD cohorts only] Must be willing to receive vaccinations for encapsulated bacteria.
Exclusion criteria
Exclusion criteria: - Clinically significant infection (e.g., viral, bacterial, fungal, or mycobacterial) within 30*days prior to study intervention that required medical intervention (not including antibiotic prophylaxis) - Clinically significant Screening values measured after 5 minutes of rest in a seated or semi-supine position include: * Abnormal systolic blood pressure ( 140 mmHg). * Abnormal diastolic blood pressure ( 90 mmHg). * Body temperature (> 38°C). * Respiration rate at rest (> 20 per minute). * Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions - Has clinically significant laboratory abnormalities (at Screening) including: * Serum creatinine > upper limit of normal (ULN). * Estimated creatinine clearance of 1.5 x ULN. * Total bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if total bilirubin is fractionated and direct bilirubin 450 msec for male participants or >470 msec for female participants. * Abnormal sinus rhythm (heart rate 100 bpm). * Average QRS interval > 120 msec after being confirmed by manual over-read. * Average PR interval > 220 msec. * Resting bradycardia (ventricular rate [VR] 90 bpm) on Screening ECG. - An antinuclear antibodies (ANA) 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 mL within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening - Unable to consume a high-fat diet, if selected for the FE part of the study. - Has experienced symptoms of acute illness or chronic disease within 14 days prior to Screening, or any disease or condition (medical or surgical) that, by the determination of the Investigator, might compromise interpretation of safety or PK data, or would place the participant at risk because of participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAD part: Incidence and severity of treatment emergent adverse events (TEAEs) and clinically significant abnormalities in vital signs, clinical laboratory tests, and electrocardiogram (ECG) after single oral doses. MAD part: Incidence and severity of TEAEs and clinically significant abnormalities in vital signs, clinical laboratory tests, and ECGs after multiple doses (over 14 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| SAD part: - Plasma ANX1502 and ANX1439 concentrations over time. - ANX1502 and ANX1439 Day 1 plasma PK parameters (e.g., maximum observed plasma concentration [Cmax], observed time to Cmax [Tmax], area under the concentration-time curve [AUCs], terminal half-life [t1/2]. MAD part: - Plasma ANX1502 and ANX1439 concentrations over time. - ANX1502 and ANX1439 Day 1 and Day 14 plasma PK parameters (e.g., Cmax and Tmax, AUCs and t1/2 minimum observed plasma concentration [Cmin], average observed plasma concentration during multiple-dose administration [Cave], %fluctuation, and accumulation ratio). | — |
Countries
Netherlands
Outcome results
None listed