Conditions: Healthy
Keywords: ALXN1210 Pharmacokinetics Pharmacodynamics
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 16
Healthy volunteers: yes

Brief summary:
This study evaluated the safety and tolerability of multiple doses of ALXN1210 (400 and 800 milligrams \[mg\]) following intravenous (IV) administration to healthy participants.

Detailed description:
Participants were divided into 2 cohorts and were randomly assigned in a 3:1 ratio to receive IV ALXN1210 or placebo. Participants in Cohort 1 received 5 IV doses of 400 mg of ALXN1210 or placebo administered every 28 days. To determine if dose continuation and dose escalation to Cohort 2 should occur, the Safety Review Committee conducted a blinded review of the available safety data after Day 15 of the second dose of the last participant in Cohort 1. Participants in Cohort 2 received 5 doses of 400 mg of ALXN1210 or placebo and 5 IV doses of 800 mg of ALXN1210 or placebo administered intravenously every 28 days. Safety, PK, PD, and immunogenicity assessments were performed during the Follow-up Period after the last dose.

Arms:
arm 1: Participants received ALXN1210 every 28 days. arm 2: Participants received ALXN1210 every 28 days. arm 3: Participants received placebo every 28 days.

Interventions: intervention 1: ALXN1210 intervention 2: Placebo
Intervention descriptions: intervention 1: ALXN1210 was administered by IV infusion over 5 periods, 1 dose per period: Period 1, induction; Periods 2-5, maintenance. Participants received a total of 5 doses of 400 or 800 mg, each administered every 28 days. intervention 2: Placebo was administered by IV infusion over 5 periods, 1 dose per period. Participants received the same volume and infusion rate as specified for each ALXN1210 dose (400 or 800 mg).

Protocol document: