Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920370
• Other study ID #: ALXN1720-HV-101
• Secondary ID: 2018-004500-19
• Status: Completed
• Phase: Phase 1
• Start date: September 4, 2019
• Est. completion date: November 16, 2021

Study information

• Verified date: January 2022
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN1720 SC
ALXN1720 will be administered via SC route.
• ALXN1720 IV
ALXN1720 will be administered via IV route.
• rHuPH20
rHuPH20 will be administered via SC route.
• Placebo SC
Placebo will be administered via SC route.
• Placebo IV
Placebo will be administered via IV route.

Locations

Country	Name	City	State
United Kingdom	Clinical Study Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

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