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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04631562




Registration number
NCT04631562
Ethics application status
Date submitted
13/11/2020
Date registered
17/11/2020

Titles & IDs
Public title
Study of ALXN1820 in Healthy Adult Participants
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants
Secondary ID [1] 0 0
2021-002472-39
Secondary ID [2] 0 0
ALXN1820-HV-101
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 - ALXN1820 SC
Treatment: Drugs - ALXN1820 IV
Treatment: Drugs - Placebo SC
Treatment: Drugs - Placebo IV

Experimental: ALXN1820 - Participants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only.

Placebo comparator: Placebo - Participants will receive Placebo SC or Placebo IV according to their assigned cohort.


Treatment: Drugs: ALXN1820 SC
ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.

Treatment: Drugs: ALXN1820 IV
ALXN1820 IV (450 mg) will be administered as an IV infusion.

Treatment: Drugs: Placebo SC
Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.

Treatment: Drugs: Placebo IV
Placebo IV will be administered as an IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV
Timepoint [1] 0 0
Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155
Secondary outcome [1] 0 0
Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts
Timepoint [1] 0 0
Up to 126 days following the first day of dosing
Secondary outcome [2] 0 0
Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts
Timepoint [2] 0 0
Up to 154 days following the first day of dosing
Secondary outcome [3] 0 0
Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts
Timepoint [3] 0 0
Up to 126 days following the first day of dosing
Secondary outcome [4] 0 0
Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts
Timepoint [4] 0 0
Up to 154 days following the first day of dosing
Secondary outcome [5] 0 0
Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Timepoint [5] 0 0
Baseline, Day 127
Secondary outcome [6] 0 0
Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Timepoint [6] 0 0
Baseline, Day 127
Secondary outcome [7] 0 0
Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts
Timepoint [7] 0 0
Baseline, Day 155
Secondary outcome [8] 0 0
Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts
Timepoint [8] 0 0
Baseline, Day 155
Secondary outcome [9] 0 0
Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts
Timepoint [9] 0 0
Baseline, Day 127
Secondary outcome [10] 0 0
Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts
Timepoint [10] 0 0
Baseline, Day 155
Secondary outcome [11] 0 0
Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV
Timepoint [11] 0 0
Baseline up to Day 155
Secondary outcome [12] 0 0
Absolute Bioavailability Of ALXN1820 SC
Timepoint [12] 0 0
Baseline up to Day 127

Eligibility
Key inclusion criteria
* Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
* Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
* Satisfactory medical assessment.
* Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
* Vaccination requirement:

* Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
* Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Current/recurrent diseases or relevant medical history.
* History of any Neisseria infection.
* Hepatitis B/C, human immunodeficiency virus.
* History of latent or active tuberculosis (TB), or positive TB test.
* Active systemic infection within 14 days of dosing.
* Risk of meningococcal infections due to living/working conditions.
* History of complement deficiency or complement activity below the reference range.
* Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
* Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
* Acquired complement deficiencies (for example, those receiving eculizumab).

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
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
13/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2022
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
London

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)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04631562