Healthy Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
Verified date | January 2022 |
Source | Alexion Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
Status | Completed |
Enrollment | 97 |
Est. completion date | November 16, 2021 |
Est. primary completion date | November 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Study Site | London |
Lead Sponsor | Collaborator |
---|---|
Alexion Pharmaceuticals |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs) | Up to 176 days following the first day of dosing | ||
Secondary | Maximum Observed Concentration (Cmax) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV | Up to 176 days following the first day of dosing | ||
Secondary | Area Under The Concentration-time Curve (AUC) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV | Up to 176 days following the first day of dosing | ||
Secondary | Change from Baseline in Serum Concentrations of Free Complement Component 5 (C5) | Baseline, 176 days following the first day of dosing | ||
Secondary | Change from Baseline in Serum Concentrations of Total C5 | Baseline, 176 days following the first day of dosing | ||
Secondary | Change from Baseline in Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity | Baseline, 176 days following the first day of dosing | ||
Secondary | Incidence of Antidrug Antibodies (ADAs) to ALXN1720 | Up to 176 days following the first day of dosing | ||
Secondary | Absolute Bioavailability of ALXN1720 | The absolute bioavailability for ALXN1720 SC will be defined by the ratio of the geometric means for AUC for ALXN1720 SC over ALXN1720 IV after a single dose. | Up to 176 days following the first day of dosing | |
Secondary | Comparison of Incidence of TEAEs and SAEs Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing | ||
Secondary | Comparison of Cmax of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing | ||
Secondary | Comparison of AUC of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing | ||
Secondary | Comparison of Change from Baseline in Serum Concentrations of Free C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Baseline, 176 days following the first day of dosing | ||
Secondary | Comparison of Change from Baseline in Serum Concentrations of Total C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Baseline, 176 days following the first day of dosing | ||
Secondary | Comparison of Change from Baseline in Serum Concentrations in Ex Vivo cRBC Hemolysis Activity Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Baseline, 176 days following the first day of dosing | ||
Secondary | Comparison of ADAs to ALXN1720 Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing |
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