Status:
COMPLETED
Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
Detailed Description
Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo. The study will be conducted in healthy adult participants, including participants of Japanese descent.
Eligibility Criteria
Inclusion
- Body weight within 50 to 90 kilograms (kg), inclusive, and body mass index within the range of 18 to 29.9 kg/meter squared, inclusive.
- Willing to follow protocol-specified contraception guidance while on treatment and for 6 months after the last dose of study treatment.
- Vaccination with tetravalent meningococcal conjugate vaccine and serogroup B meningococcal vaccine.
- No clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation.
- For the cohorts with Japanese participants, parents and grandparents must both be Japanese, and participants must have resided for less than 5 years outside of Japan.
Exclusion
- Current or recurrent disease that could affect clinical assessments or clinical laboratory evaluations.
- History of complement deficiency or complement activity below the reference range.
- Female participants who are breastfeeding.
- Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study. Immunization with inactivated or recombinant influenza vaccine, or nucleoside-modified messenger ribonucleic acid or recombinant COVID-19 vaccine is permitted.
- Current tobacco smoking, history of illicit drug abuse, or history of significant alcohol abuse.
Key Trial Info
Start Date :
September 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2021
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04920370
Start Date
September 4 2019
End Date
November 16 2021
Last Update
February 11 2022
Active Locations (1)
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1
Clinical Study Site
London, United Kingdom