A Study of Single-dose ALXN2050 in Healthy Adults
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1: 40 mg ALXN2050/Placebo Participants randomized to receive ALXN2050 or placebo on Day 1. |
Drug: ALXN2050
Powder-in-capsule (PIC).
Other Names:
Drug: Placebo
PIC.
|
Experimental: Cohort 2: 80 mg ALXN2050/Placebo Participants randomized to receive ALXN2050 or placebo on Day 1. |
Drug: ALXN2050
Powder-in-capsule (PIC).
Other Names:
Drug: Placebo
PIC.
|
Experimental: Cohort 3: 120 mg ALXN2050/Placebo Participants randomized to receive ALXN2050 or placebo on Day 1. |
Drug: ALXN2050
Powder-in-capsule (PIC).
Other Names:
Drug: Placebo
PIC.
|
Outcome Measures
Primary Outcome Measures
- 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]
- Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities [Day 1 through Day 42]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clinical Trial Site | Auckland | New Zealand |
Sponsors and Collaborators
- Alexion Pharmaceuticals
- Achillion, a wholly owned subsidiary of Alexion
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACH228-001
- ACTRN12617001521314
- U1111-1203-1371