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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04730804




Registration number
NCT04730804
Ethics application status
Date submitted
26/01/2021
Date registered
29/01/2021

Titles & IDs
Public title
A Study of ALXN1830 in Healthy Adult Participants
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
Secondary ID [1] 0 0
2020-001081-11
Secondary ID [2] 0 0
ALXN1830-HV-108
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 - ALXN1830
Treatment: Drugs - Placebo

Experimental: Cohort 1: ALXN1830 Single Dose 1/Placebo - Participants will receive a single SC dose of ALXN1830 or placebo.

Experimental: Cohort 2: ALXN1830 Single Dose 2/Placebo - Participants will receive a single SC dose of ALXN1830 or placebo.

Experimental: Cohort 3: ALXN1830 Multiple Dose 1/Placebo - Participants will receive multiple SC doses of ALXN1830 or placebo.

Experimental: Cohort 4: ALXN1830 Multiple Dose 2/Placebo - Participants will receive multiple SC doses of ALXN1830 or placebo.

Experimental: Cohort 5: ALXN1830 Multiple Dose 3/Placebo - Participants will receive multiple SC doses of ALXN1830 or placebo.

Experimental: Cohort 6: ALXN1830 /Placebo in Japanese Population - Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.


Treatment: Drugs: ALXN1830
ALXN1830 will be administered as SC infusion(s).

Treatment: Drugs: Placebo
Placebo will be administered as SC infusion(s).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number Of Participants With Treatment-emergent Adverse Events
Timepoint [1] 0 0
Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration)
Secondary outcome [1] 0 0
Area Under The Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) Of Serum ALXN1830 For Single And Multiple Doses
Timepoint [1] 0 0
Up to 141 days postdose
Secondary outcome [2] 0 0
Change From Baseline In Serum Immunoglobulin G (IgG) For Single And Multiple Doses Of ALXN1830
Timepoint [2] 0 0
Up to 141 days postdose
Secondary outcome [3] 0 0
Comparison Of Incidences Of Treatment-emergent Adverse Events Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830
Timepoint [3] 0 0
Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration)
Secondary outcome [4] 0 0
Comparison Of AUC0-inf Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830
Timepoint [4] 0 0
Up to 141 days postdose
Secondary outcome [5] 0 0
Comparison Of IgG Levels Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830
Timepoint [5] 0 0
Up to 141 days postdose

Eligibility
Key inclusion criteria
* Satisfactory medical assessment.
* Participants must have had vaccination against pneumococcus (Pneumovax 23 [PPSV23]) at least 28 days, and maximally 4 years prior to Day 1.
* Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
* Body weight within 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive.
* Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Current/recurrent diseases or relevant medical history.
* Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing.
* Participants who have prior exposure to ALXN1830.
* Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
* Participants with hepatitis B or C, or human immunodeficiency virus.
* Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2022
Sample size
Target
Accrual to date
Final
48
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
Other
Name [1] 0 0
Syneos Health
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)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT04730804