Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05047458




Registration number
NCT05047458
Ethics application status
Date submitted
9/09/2021
Date registered
17/09/2021

Titles & IDs
Public title
A Study of Single-dose ALXN2050 in Healthy Adults
Scientific title
A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Volunteers
Secondary ID [1] 0 0
ACTRN12617001521314
Secondary ID [2] 0 0
ACH228-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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 on Day 1.

Experimental: Cohort 2: 80 mg ALXN2050/Placebo - Participants randomized to receive ALXN2050 or placebo on Day 1.

Experimental: Cohort 3: 120 mg ALXN2050/Placebo - Participants randomized to receive ALXN2050 or placebo on Day 1.


Treatment: Drugs: ALXN2050
Powder-in-capsule (PIC).

Treatment: Drugs: Placebo
PIC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number Of Participants Experiencing Serious Adverse Events
Timepoint [1] 0 0
Day 1 through Day 42
Primary outcome [2] 0 0
Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)
Timepoint [2] 0 0
Day 1 through Day 42
Primary outcome [3] 0 0
Number Of Participants Experiencing AEs Leading To Discontinuation From The Study
Timepoint [3] 0 0
Day 1 through Day 42
Primary outcome [4] 0 0
Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities
Timepoint [4] 0 0
Day 1 through Day 42
Primary outcome [5] 0 0
Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
Timepoint [5] 0 0
Day 1 through Day 42
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) Of ALXN2050
Timepoint [1] 0 0
Up to 144 hours postdose
Secondary outcome [2] 0 0
Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050
Timepoint [2] 0 0
Up to 144 hours postdose
Secondary outcome [3] 0 0
Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050
Timepoint [3] 0 0
Up to 144 hours postdose
Secondary outcome [4] 0 0
Alternative Pathway (AP) Activity As Measured By Wieslab Assay
Timepoint [4] 0 0
Up to 144 hours postdose
Secondary outcome [5] 0 0
Plasma Bb Fragment Of Complement Factor B Concentration Over Time
Timepoint [5] 0 0
Up to 144 hours postdose

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2018
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Achillion, a wholly owned subsidiary of Alexion
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05047458