Status:
COMPLETED
A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects
Lead Sponsor:
Akesobio Australia Pty Ltd
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04516564
Start Date
September 28 2020
End Date
June 21 2021
Last Update
February 28 2025
Active Locations (1)
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1
Christchurch Clinical Studies Trust
Christchurch, New Zealand