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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK119 | Experimental | Single dose of AK119 is administered via intravenous infusion to healthy subjects. |
|
| Placebo | Experimental | Single dose of placebo is administered via intravenous infusion to healthy subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK119 | Drug | Single dose of AK119 is administered via intravenous infusion to healthy subjects |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent AEs | From signing of informed consent till end of study (approximately 64 days postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Subjects must meet ALL the following inclusion criteria (as applicable) to be eligible for participation in this study:
Exclusion Criteria:
Subjects who meet ANY of the following exclusion criteria will not be enrolled in this study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch Clinical Studies Trust | Christchurch | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo |
| Drug |
Single dose of placebo is administered via intravenous infusion to healthy subjects |
|
| Percentage of subjects who develop detectable anti-drug antibodies (ADAs) | From baseline till end of study (approximately 64 days postdose) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |