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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05047484
Registration number
NCT05047484
Ethics application status
Date submitted
9/09/2021
Date registered
17/09/2021
Date last updated
17/09/2021
Titles & IDs
Public title
A Study of Multiple Doses of ALXN2050 in Healthy Adults
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Scientific title
A Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Participants
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Secondary ID [1]
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ACH228-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ALXN2050
Treatment: Drugs - Placebo
Experimental: Cohort 1: 40 mg ALXN2050/Placebo - Participants randomized to receive ALXN2050 or placebo twice daily (BID) on Day 1 through Day 14 in a fasted state.
Experimental: Cohort 2: 80 mg ALXN2050/Placebo - Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state.
Experimental: Cohort 3: 120 mg ALXN2050/Placebo - Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state.
Experimental: Cohort 4: 200 mg ALXN2050/Placebo - Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state.
Experimental: Cohort 5: 120 mg ALXN2050/Placebo - Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fed state.
Experimental: Cohort 6: 240 mg ALXN2050/Placebo - Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fasted state.
Treatment: Drugs: ALXN2050
Powder-in-capsule (PIC).
Treatment: Drugs: Placebo
PIC.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number Of Participants Experiencing Serious Adverse Events
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Assessment method [1]
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Timepoint [1]
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Day 1 through Day 42
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Primary outcome [2]
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Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)
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Assessment method [2]
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Timepoint [2]
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Day 1 through Day 42
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Primary outcome [3]
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Number Of Participants Experiencing AEs Leading To Discontinuation From The Study
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Assessment method [3]
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Timepoint [3]
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Day 1 through Day 42
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Primary outcome [4]
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Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities
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Assessment method [4]
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Timepoint [4]
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Day 1 through Day 42
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Primary outcome [5]
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Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
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Assessment method [5]
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Timepoint [5]
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Day 1 through Day 42
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Secondary outcome [1]
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Maximum Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050
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Assessment method [1]
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Timepoint [1]
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Up to 168 hours postdose
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Secondary outcome [2]
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Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050
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Assessment method [2]
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Timepoint [2]
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Up to 168 hours postdose
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Secondary outcome [3]
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Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050
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Assessment method [3]
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Timepoint [3]
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Up to 168 hours postdose
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Secondary outcome [4]
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Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050
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Assessment method [4]
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Timepoint [4]
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Up to 72 hours postdose
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Secondary outcome [5]
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Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050
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Assessment method [5]
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Timepoint [5]
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Up to 72 hours postdose
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Secondary outcome [6]
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Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050
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Assessment method [6]
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Timepoint [6]
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Up to 72 hours postdose
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Secondary outcome [7]
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Alternative Pathway (AP) Activity As Measured By Wieslab Assay
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Assessment method [7]
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Timepoint [7]
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Up to 14 days postdose
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Secondary outcome [8]
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Plasma Bb Fragment Of Complement Factor B Concentration Over Time
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Assessment method [8]
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Timepoint [8]
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Up to 14 days postdose
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Eligibility
Key inclusion criteria
Key
- 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.
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Minimum age
25
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/07/2019
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alexion Pharmaceuticals, Inc.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Achillion, a wholly owned subsidiary of Alexion
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05047484
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05047484
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