At a glance
ClinicalIndex Comparison Record- ✓Body mass index 18–29.9 kg/m² and weight 50–100 kg
- ✓QT interval ≤450 msec (males) or ≤470 msec (females) at Screening and Day 1
- ✓Tetravalent meningococcal conjugate vaccine ≥56 days and ≤3 years prior to dosing, with documented positive serum bactericidal antibody titer
- ✓Serogroup B meningococcal vaccine ≥56 days prior to dosing with booster ≥28 days prior, with ≥28 days between first and second injections
- ✕Intimate/prolonged contact with people <2 years or >65 years of age, or immunocompromised individuals, or those with asplenia, congenital/acquired complement deficiencies, or HIV
- ✕Occupational/environmental meningococcal exposure risk (laboratory work, military recruit training, daycare work, college/university residence, travel to endemic areas)
- ✕History of Neisseria infection
- ✕Recurrent infection or infection requiring systemic antibiotics within 90 days prior to dosing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a Single Dose of ALXN1210 Administered Subcutaneously Compared to Intravenously in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating ALXN1210 SC, ALXN1210 IV, and 1 other intervention for Healthy. Completed, enrolled 42 participants across 1 site.
Detailed Summary
This study evaluated the safety and tolerability of a single dose of ALXN1210 subcutaneous (SC) compared to ALXN1210 intravenous (IV) in healthy participants and to determine the absolute bioavailability of ALXN1210 SC.
Study Details
Timeline
Interventions
All doses of ALXN1210 SC were administered by four 100-milligram (mg) SC injections of 1 milliliter (mL) each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.
All doses of ALXN1210 IV were administered by IV infusion, using IV sets with in-line filters, at a maximum rate of 333 mL/hour, excluding interruption for safety or technical reason. There were at least 15 minutes between the end-of-infusion/injection in 1 participant and the start-of infusion/injection in the next participant.
All doses of placebo SC were administered by four 100-mg SC injections of 1 mL each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.