Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
Study Identifier:
ALXN1720-HV-101
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN1720 SC
- Drug: ALXN1720 IV
- Drug: rHuPH20
- Drug: Placebo SC
- Drug: Placebo IV
Date
Sep 2019 - Nov 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 45 Years
Requirements Information
Inclusion and Exclusion Criteria
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.
Sex
Female & Male
Age
18 - 45 Years
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN1720 SC
- Drug: ALXN1720 IV
- Drug: rHuPH20
- Drug: Placebo SC
- Drug: Placebo IV
Date
Sep 2019 - Nov 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 45 Years years
Requirements Information
Inclusion and Exclusion Criteria
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.
Protocol Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
Trial Locations
Location
Status
Location
Clinical Study Site
London, United Kingdom
Status
N/A