A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects
- Registration Number
- NCT04516564
- Lead Sponsor
- Akesobio Australia Pty Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description AK119 AK119 Single dose of AK119 is administered via intravenous infusion to healthy subjects. Placebo Placebo Single dose of placebo is administered via intravenous infusion to healthy subjects.
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent AEs From signing of informed consent till end of study (approximately 64 days postdose)
- Secondary Outcome Measures
Name Time Method Maximum serum concentration (Cmax) of AK119 From baseline till end of study (approximately 64 days postdose) Area under the concentration-time curve (AUC) of serum concentration of AK119 From baseline till end of study (approximately 64 days postdose) Percentage of subjects who develop detectable anti-drug antibodies (ADAs) From baseline till end of study (approximately 64 days postdose)
Trial Locations
- Locations (1)
Christchurch Clinical Studies Trust
🇳🇿Christchurch, New Zealand