Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants

Study Identifier:
ALXN2080-HV-101
ClinicalTrials.gov Identifier:
NCT05428696
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN2080
  • Drug: Placebo
Date
Sep 2022 - Apr 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
  • Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
  • Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.
Exclusion Criteria
  • Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
  • History of hypersensitivity to any ingredient contained in the study intervention.
  • Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
  • Known or suspected history of drug or alcohol abuse or dependence.
  • Current tobacco users or smokers.
  • Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • For females: pregnant, breastfeeding, or intending to conceive during the course of the study.
Sex
Female & Male
Age
18 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN2080
  • Drug: Placebo
Date
Sep 2022 - Apr 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
  • Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
  • Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.
Exclusion Criteria
  • Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
  • History of hypersensitivity to any ingredient contained in the study intervention.
  • Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
  • Known or suspected history of drug or alcohol abuse or dependence.
  • Current tobacco users or smokers.
  • Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • For females: pregnant, breastfeeding, or intending to conceive during the course of the study.

Protocol Summary

This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.

Trial Locations

Location
Status
Location
Clinical Trial Site
Belfast, United Kingdom, BT9 6AD
Status
N/A