Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/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
34
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 are available at https://clinicaltrials.gov/study/NCT04730804