A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants

Launched by ALEXION PHARMACEUTICALS, INC. · Feb 15, 2022

Keywords

ClinConnect Summary

This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Satisfactory medical assessment.
• • Participants must have had vaccination against pneumococcus (Pneumovax 23 \[PPSV23\]) at least 28 days, and maximally 4 years prior to Day 1.
• • Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
• • Body weight within 50 to 90 kg, inclusive, and body mass index (BMI) within the range of 18 to 24.9 kg/m\^2, inclusive.
• • Must be willing to follow protocol-specified contraception guidance during the study and for up to 3 months after last dose of study drug.
• Exclusion Criteria:
• • Current/recurrent diseases or relevant medical history.
• • Known exposure to therapeutic proteins, such as monoclonal antibodies, including marketed drugs prior to dosing.
• • Participants who have prior exposure to ALXN1830.
• • Exposure to more than 4 new (small molecule) investigational compounds within 12 months prior to dosing.
• • Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
• • Presence of hepatitis B surface antigen (HBsAg) at Screening.
• • Positive hepatitis C antibody test result at Screening.
• • Positive human immunodeficiency virus (HIV) antibody test at Screening.
• • Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies