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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
Date last updated
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
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.
Trial website
https://clinicaltrials.gov/study/NCT05047458
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05047458