Clinical trial NCT05047458: A Study of Single-dose ALXN2050 in Healthy Adults
Official title: A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Volunteers
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: 28
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, 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.


Eligibility 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.

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 Plasma Concentration (Cmax) Of ALXN2050
timeFrame: Up to 144 hours postdose
measure: Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050
timeFrame: Up to 144 hours postdose
measure: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050
timeFrame: Up to 144 hours postdose
measure: Alternative Pathway (AP) Activity As Measured By Wieslab Assay
timeFrame: Up to 144 hours postdose
measure: Plasma Bb Fragment Of Complement Factor B Concentration Over Time
timeFrame: Up to 144 hours postdose
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Clinical Trial Site
Study officials:
References: