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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
Scientific title
A Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Participants
Secondary ID [1] 0 0
ACH228-002
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 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.
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 Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050
Timepoint [1] 0 0
Up to 168 hours postdose
Secondary outcome [2] 0 0
Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050
Timepoint [2] 0 0
Up to 168 hours postdose
Secondary outcome [3] 0 0
Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050
Timepoint [3] 0 0
Up to 168 hours postdose
Secondary outcome [4] 0 0
Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050
Timepoint [4] 0 0
Up to 72 hours postdose
Secondary outcome [5] 0 0
Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050
Timepoint [5] 0 0
Up to 72 hours postdose
Secondary outcome [6] 0 0
Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050
Timepoint [6] 0 0
Up to 72 hours postdose
Secondary outcome [7] 0 0
Alternative Pathway (AP) Activity As Measured By Wieslab Assay
Timepoint [7] 0 0
Up to 14 days postdose
Secondary outcome [8] 0 0
Plasma Bb Fragment Of Complement Factor B Concentration Over Time
Timepoint [8] 0 0
Up to 14 days postdose

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.

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 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.

Study design
Purpose of the study
Basic Science
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
7/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/07/2019
Sample size
Target
Accrual to date
Final
45
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, 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05047484
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