Status:
COMPLETED
Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Celerion
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed Description
Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be admi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05428696
Start Date
September 12 2022
End Date
May 26 2023
Last Update
June 7 2024
Active Locations (1)
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1
Clinical Trial Site
Belfast, United Kingdom, BT9 6AD