A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants
Study Identifier:
ALXN1830-HV-105
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Available Documents
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN1830
- Drug: Placebo
Date
Nov 2019 - Jan 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion 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
Sex
Female & Male
Age
18 - 65 Years
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN1830
- Drug: Placebo
Date
Nov 2019 - Jan 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years years
Requirements Information
Inclusion and Exclusion 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
Protocol Summary
This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.
Trial Locations
Location
Status
Location
Clinical Trial Site
London, United Kingdom
Status
N/A