A Study of Multiple Doses of ALXN2050 in Healthy Adults
- Registration Number
- NCT05047484
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Was overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- Had a body weight of at least 50 kilograms (kg) and body mass index within the range of 18 to 30 kg/meter squared (inclusive).
- Male participants were eligible to participate if they agreed to abstinence or use of a highly effective method of contraception.
- Female participants must have been of nonchildbearing potential.
Key
Exclusion Criteria
- Had a history or clinically relevant evidence of current cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- 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 sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicated participation in the study.
- Donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration.
- Current enrollment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research
- Had clinically significant laboratory abnormalities.
- Positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: 80 mg ALXN2050/Placebo Placebo Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Cohort 1: 40 mg ALXN2050/Placebo ALXN2050 Participants randomized to receive ALXN2050 or placebo twice daily (BID) on Day 1 through Day 14 in a fasted state. Cohort 1: 40 mg ALXN2050/Placebo Placebo Participants randomized to receive ALXN2050 or placebo twice daily (BID) on Day 1 through Day 14 in a fasted state. Cohort 3: 120 mg ALXN2050/Placebo Placebo Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Cohort 4: 200 mg ALXN2050/Placebo Placebo Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Cohort 5: 120 mg ALXN2050/Placebo ALXN2050 Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fed state. Cohort 5: 120 mg ALXN2050/Placebo Placebo Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fed state. Cohort 6: 240 mg ALXN2050/Placebo ALXN2050 Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fasted state. Cohort 6: 240 mg ALXN2050/Placebo Placebo Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fasted state. Cohort 2: 80 mg ALXN2050/Placebo ALXN2050 Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Cohort 3: 120 mg ALXN2050/Placebo ALXN2050 Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Cohort 4: 200 mg ALXN2050/Placebo ALXN2050 Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state.
- Primary Outcome Measures
Name Time Method Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities Day 1 through Day 42 Number Of Participants Experiencing AEs Leading To Discontinuation From The Study Day 1 through Day 42 Number Of Participants Experiencing Serious Adverse Events Day 1 through Day 42 Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs) Day 1 through Day 42 Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities Day 1 through Day 42
- Secondary Outcome Measures
Name Time Method Plasma Bb Fragment Of Complement Factor B Concentration Over Time Up to 14 days postdose Maximum Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050 Up to 168 hours postdose Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050 Up to 168 hours postdose Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050 Up to 168 hours postdose Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050 Up to 72 hours postdose Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050 Up to 72 hours postdose Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050 Up to 72 hours postdose Alternative Pathway (AP) Activity As Measured By Wieslab Assay Up to 14 days postdose
Trial Locations
- Locations (1)
Clinical Trial Site
🇳🇿Auckland, New Zealand