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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
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
Secondary ID [1] 0 0
AK119-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease 2019 (COVID-19) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent AEs
Timepoint [1] 0 0
From signing of informed consent till end of study (approximately 64 days postdose)
Secondary outcome [1] 0 0
Maximum serum concentration (Cmax) of AK119
Timepoint [1] 0 0
From baseline till end of study (approximately 64 days postdose)
Secondary outcome [2] 0 0
Area under the concentration-time curve (AUC) of serum concentration of AK119
Timepoint [2] 0 0
From baseline till end of study (approximately 64 days postdose)
Secondary outcome [3] 0 0
Percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Timepoint [3] 0 0
From baseline till end of study (approximately 64 days postdose)

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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
29/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2021
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Akesobio Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04516564
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