Healthy
Conditions
Keywords
Factor D Inhibitor, Complement, ALXN2050, ACH-0145228, Pharmacokinetics, Pharmacodynamics, Safety
Brief 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.
Interventions
DRUGALXN2050
Powder-in-capsule (PIC).
DRUGPlacebo
PIC.
Sponsors
Achillion, a wholly owned subsidiary of Alexion
Alexion Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key 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. Key
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities | 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 AEs Leading To Discontinuation From The Study | Day 1 through Day 42 |
| Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities | Day 1 through Day 42 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) Of ALXN2050 | Up to 144 hours postdose |
| Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050 | Up to 144 hours postdose |
| Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050 | Up to 144 hours postdose |
| Alternative Pathway (AP) Activity As Measured By Wieslab Assay | Up to 144 hours postdose |
| Plasma Bb Fragment Of Complement Factor B Concentration Over Time | Up to 144 hours postdose |
Countries
New Zealand
Outcome results
None listed