A Study of Single-dose ALXN2050 in Healthy Adults

Study Identifier:
ACH228-001
ClinicalTrials.gov Identifier:
NCT05047458
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: ALXN2050
  • Drug: Placebo
Date
Nov 2017 - Apr 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 25 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy was 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.
  • Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
  • Female participant of nonchildbearing potential.
  • Male participant agreed to abstinence or use of a highly effective form of contraception.
Exclusion Criteria
  • Had a history or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • Had any condition possibly affecting drug absorption.
  • Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
  • Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.
  • Had participated in a clinical study within 30 days prior to first study drug administration
  • Had clinically significant laboratory abnormalities,
  • Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.
  • Had a clinically significant history of drug allergy.
Sex
Female & Male
Age
25 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN2050
  • Drug: Placebo
Date
Nov 2017 - Apr 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 25 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy was 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.
  • Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
  • Female participant of nonchildbearing potential.
  • Male participant agreed to abstinence or use of a highly effective form of contraception.
Exclusion Criteria
  • Had a history or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • Had any condition possibly affecting drug absorption.
  • Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
  • Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.
  • Had participated in a clinical study within 30 days prior to first study drug administration
  • Had clinically significant laboratory abnormalities,
  • Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.
  • Had a clinically significant history of drug allergy.

Protocol Summary

This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.

Trial Locations

Location
Status
Location
Clinical Trial Site
Auckland, New Zealand
Status
N/A