Clinical trial NCT05047484: A Study of Multiple Doses of ALXN2050 in Healthy Adults
Official title: A Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Factor D Inhibitor
Complement
ALXN2050
ACH-0145228
Pharmacokinetics
Pharmacodynamics
Safety
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2021-09-17
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: Key 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.

Primary outcomes:
measure: Number Of Participants Experiencing Serious Adverse Events
timeFrame: Day 1 through Day 42
measure: Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)
timeFrame: Day 1 through Day 42
measure: Number Of Participants Experiencing AEs Leading To Discontinuation From The Study
timeFrame: Day 1 through Day 42
measure: Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities
timeFrame: Day 1 through Day 42
measure: Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
timeFrame: Day 1 through Day 42
Secondary outcomes:
measure: Maximum Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050
timeFrame: Up to 168 hours postdose
measure: Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050
timeFrame: Up to 168 hours postdose
measure: Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050
timeFrame: Up to 168 hours postdose
measure: Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Alternative Pathway (AP) Activity As Measured By Wieslab Assay
timeFrame: Up to 14 days postdose
measure: Plasma Bb Fragment Of Complement Factor B Concentration Over Time
timeFrame: Up to 14 days postdose
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Clinical Trial Site
Study officials:
References: