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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/NCT04516564
Registration number
NCT04516564
Ethics application status
Date submitted
13/08/2020
Date registered
18/08/2020
Date last updated
18/10/2021
Titles & IDs
Public title
A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects
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Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AK119 in Healthy Subjects
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Secondary ID [1]
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AK119-101
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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:
Coronavirus Disease 2019 (COVID-19)
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AK119
Treatment: Drugs - Placebo
Experimental: AK119 - Single dose of AK119 is administered via intravenous infusion to healthy subjects.
Experimental: Placebo - Single dose of placebo is administered via intravenous infusion to healthy subjects.
Treatment: Drugs: AK119
Single dose of AK119 is administered via intravenous infusion to healthy subjects
Treatment: Drugs: Placebo
Single dose of placebo is administered via intravenous infusion to healthy subjects
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Intervention code [1]
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Treatment: Drugs
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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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Incidence of treatment-emergent AEs
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Assessment method [1]
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Timepoint [1]
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From signing of informed consent till end of study (approximately 64 days postdose)
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Secondary outcome [1]
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Maximum serum concentration (Cmax) of AK119
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Assessment method [1]
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Timepoint [1]
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From baseline till end of study (approximately 64 days postdose)
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Secondary outcome [2]
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Area under the concentration-time curve (AUC) of serum concentration of AK119
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Assessment method [2]
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Timepoint [2]
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From baseline till end of study (approximately 64 days postdose)
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Secondary outcome [3]
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Percentage of subjects who develop detectable anti-drug antibodies (ADAs)
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Assessment method [3]
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Timepoint [3]
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From baseline till end of study (approximately 64 days postdose)
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Eligibility
Key inclusion criteria
Subjects must meet ALL the following inclusion criteria (as applicable) to be eligible for
participation in this study:
- Adults between 18 and 55 years of age, inclusive, at screening.
- Must have a calculated body mass index (BMI, weight [kg]/height [m2]) within 18.0 to
30.0 kg/m2 (inclusive) at screening, and a total body weight =50 kg for men or =45 kg
for women at screening and Day -1 before randomization.
- Must, in the opinion of the Investigator, be in good general health based upon medical
history, physical examination (including vital signs), and 12-lead ECG; and clinical
laboratory tests (up to 1 repeat permitted) must fall within the clinical laboratory"s
reference normal ranges.
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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
Subjects who meet ANY of the following exclusion criteria will not be enrolled in this
study
- Have a history of latent or active granulomatous infection, including histoplasmosis,
candidiasis, or coccidioidomycosis prior to screening, or a history of any other
infectious disease within 4 weeks prior to screening that, in the opinion of the
Investigator, affects the subject"s ability to participate in the study.
- Have a history of multiple drug allergies or a known allergy or hypersensitivity to
any biologic therapy at screening that is important in the opinion of the
Investigator.
- Have a known allergy or reaction to any component of the AK119 formulation.
- Have any known malignancy or have a history of malignancy within the previous 5 years.
- Have a 12-lead ECG demonstrating QTcF interval > 450 msec for male subjects and >470
msec for female subjects at screening and Day -1 from average of 3 ECGs obtained after
5 minutes of supine rest.
- Blood pressure (BP) >150 mmHg (systolic) or > 95 mmHg (diastolic) at screening and Day
-1, following at least 5 minutes of supine rest.
- Have had a live vaccination within 12 weeks prior to the study dosing or intend to
have a live vaccination during the course of the study or have participated in a
vaccine clinical study within 12 weeks prior to the study dosing.
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Study design
Purpose of the study
Other
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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
29/09/2020
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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
18/06/2021
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Sample size
Target
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Accrual to date
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Final
29
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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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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Akesobio Australia Pty Ltd
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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 is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind,
placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and
immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will
consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort,
randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or
matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving
placebo) will participate in this study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04516564
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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/NCT04516564
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