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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/NCT05751642
Registration number
NCT05751642
Ethics application status
Date submitted
21/02/2023
Date registered
2/03/2023
Date last updated
13/12/2023
Titles & IDs
Public title
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants
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Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1920 in Healthy Adult Participants
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Secondary ID [1]
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ALXN1920-HV-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Participants
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - ALXN1920
Other interventions - Placebo
Other interventions - ALXN1920
Other interventions - 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.
Other interventions: ALXN1920
Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.
Other interventions: Placebo
Participants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion.
Other interventions: ALXN1920
Participants will receive a single dose of ALXN1920 by SC infusion.
Other interventions: ALXN1920
Participants will receive a single dose of ALXN1920 by Intravenous (IV) infusion.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with Adverse events (AEs)
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Assessment method [1]
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To assess the safety and tolerability of single ascending doses of ALXN1920.
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Timepoint [1]
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Up to End of study visit (Day 29)
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Secondary outcome [1]
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Maximum observed concentration (Cmax)
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Assessment method [1]
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To assess the Cmax of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [1]
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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
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Secondary outcome [2]
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Time to maximum observed concentration (tmax)
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Assessment method [2]
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To assess the tmax of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [2]
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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
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Secondary outcome [3]
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Area under the concentration-time curve from time 0 (dosing) to the last quantifiable concentration (AUC0-t)
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Assessment method [3]
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To assess the AUC0-t of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [3]
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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
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Secondary outcome [4]
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Area under the concentration-time curve from time 0 (dosing) to time infinity (AUCinf)
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Assessment method [4]
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To assess the AUCinf of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [4]
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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
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Secondary outcome [5]
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Terminal elimination half-life (t½)
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Assessment method [5]
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To assess the t½ of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [5]
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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
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Secondary outcome [6]
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Terminal-phase elimination rate constant (?z)
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Assessment method [6]
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To assess the ?z of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [6]
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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
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Secondary outcome [7]
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Total body clearance (CL)
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Assessment method [7]
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To assess the CL of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [7]
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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
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Secondary outcome [8]
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Apparent clearance (CL/F)
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Assessment method [8]
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To assess the CL/F of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [8]
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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
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Secondary outcome [9]
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Volume of distribution (Vd)
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Assessment method [9]
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To assess the Vd of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [9]
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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
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Secondary outcome [10]
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Apparent volume of distribution (Vd/F)
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Assessment method [10]
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To assess the Vd/F of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [10]
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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
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Secondary outcome [11]
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Renal clearance (CLR)
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Assessment method [11]
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To assess the CLR of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [11]
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Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
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Secondary outcome [12]
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Amount of unchanged drug excreted in urine (Ae)
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Assessment method [12]
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To assess the Ae of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [12]
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Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
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Secondary outcome [13]
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Fraction of dose excreted in urine (fe)
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Assessment method [13]
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To assess the fe of ALXN1920 following single ascending doses of ALXN1920.
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Timepoint [13]
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Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
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Secondary outcome [14]
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Change in complement alternative pathway (CAP) activity
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Assessment method [14]
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To explore the Pharmacodynamic (PD) effects of single ascending doses of ALXN1920. CAP activity will be assessed using the CAP hemolytic assay.
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Timepoint [14]
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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
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Secondary outcome [15]
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Change in factor H
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Assessment method [15]
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To explore the PD effects of single ascending doses of ALXN1920. Change in factor H will be assessed using the factor H assay.
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Timepoint [15]
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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
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Secondary outcome [16]
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Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1920
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Assessment method [16]
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To assess the immunogenicity to ALXN1920.
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Timepoint [16]
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Day 1 pre-dose and Day 29 post-dose
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Secondary outcome [17]
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Geometric Mean Ratio (GMR) of Area Under the Curve (AUC) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1920
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Assessment method [17]
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To assess the absolute bioavailability of ALXN1920 SC.
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Timepoint [17]
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Day 29 post-dose
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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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/12/2023
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alexion Pharmaceuticals, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics
(PD), and immunogenicity of single ascending doses (SADs) of ALXN1920 subcutaneous (SC) and
of a single dose of ALXN1920 intravenous (IV) in healthy adult participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05751642
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05751642
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