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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05751642




Registration number
NCT05751642
Ethics application status
Date submitted
21/02/2023
Date registered
2/03/2023

Titles & IDs
Public title
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1920 in Healthy Adult Participants
Secondary ID [1] 0 0
ALXN1920-HV-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ALXN1920
Treatment: Other - Placebo
Treatment: Other - ALXN1920
Treatment: Other - ALXN1920

Experimental: Cohort 1 - Participants will receive a single dose of ALXN1920.

Experimental: Cohort 2 - Participants will receive a single dose of ALXN1920.

Experimental: Cohort 3 - Participants will receive a single dose of ALXN1920.

Experimental: Cohort 4 - Participants will receive a single dose of ALXN1920.

Experimental: Cohort 5 - Participants will receive a single dose of ALXN1920.

Experimental: Cohort 6: Japanese Cohort - Japanese participants will receive a single dose of ALXN1920.

Placebo comparator: Pooled Placebo - Participants will receive Placebo.


Treatment: Other: ALXN1920
Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.

Treatment: Other: Placebo
Participants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion.

Treatment: Other: ALXN1920
Participants will receive a single dose of ALXN1920 by SC infusion.

Treatment: Other: ALXN1920
Participants will receive a single dose of ALXN1920 by Intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse events (AEs)
Timepoint [1] 0 0
Up to End of study visit (Day 29)
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax)
Timepoint [1] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [2] 0 0
Time to maximum observed concentration (tmax)
Timepoint [2] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [3] 0 0
Area under the concentration-time curve from time 0 (dosing) to the last quantifiable concentration (AUC0-t)
Timepoint [3] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [4] 0 0
Area under the concentration-time curve from time 0 (dosing) to time infinity (AUCinf)
Timepoint [4] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [5] 0 0
Terminal elimination half-life (t½)
Timepoint [5] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [6] 0 0
Terminal-phase elimination rate constant (?z)
Timepoint [6] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [7] 0 0
Total body clearance (CL)
Timepoint [7] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [8] 0 0
Apparent clearance (CL/F)
Timepoint [8] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [9] 0 0
Volume of distribution (Vd)
Timepoint [9] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [10] 0 0
Apparent volume of distribution (Vd/F)
Timepoint [10] 0 0
Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Secondary outcome [11] 0 0
Renal clearance (CLR)
Timepoint [11] 0 0
Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Secondary outcome [12] 0 0
Amount of unchanged drug excreted in urine (Ae)
Timepoint [12] 0 0
Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Secondary outcome [13] 0 0
Fraction of dose excreted in urine (fe)
Timepoint [13] 0 0
Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Secondary outcome [14] 0 0
Change in complement alternative pathway (CAP) activity
Timepoint [14] 0 0
Day 1 (Pre-dose, 0.5, 1 and 2 hours post-dose), post-dose on Day 2, 3, 4, 5, 8, 15, 22, and 29
Secondary outcome [15] 0 0
Change in factor H
Timepoint [15] 0 0
Day 1 (Pre-dose, 0.5, 1 and 2 hours post-dose), post-dose on Day 2, 3, 4, 5, 8, 15, 22, and 29
Secondary outcome [16] 0 0
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1920
Timepoint [16] 0 0
Day 1 pre-dose and Day 29 post-dose
Secondary outcome [17] 0 0
Geometric Mean Ratio (GMR) of Area Under the Curve (AUC) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1920
Timepoint [17] 0 0
Day 29 post-dose

Eligibility
Key inclusion criteria
* Healthy participants
* Body mass index within 18.0 to 32.0 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg.
* Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
* For Cohort 6, participants of Japanese descent, defined as having both parents and 4 grandparents who are ethnically Japanese.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
* History of significant allergic reaction.
* History of any Neisseria infection
* Active systemic bacterial, viral, or fungal infection.
* Participants who at Day -1 are either testing positive for coronavirus disease 2019 (COVID-19), or have not had at least 4 weeks elapse of recovery time (a negative test), or are experiencing long-term COVID-19-related sequelae.
* Any major surgery within 8 weeks of Screening.
* Known or suspected history of drug or alcohol abuse.
* Current tobacco users or smokers.
* Positive Human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C viral infection.
* Female participant who are pregnant, breastfeeding, or intending to conceive during the course of the study.

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 administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
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
24/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/12/2023
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

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?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT05751642