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| Name | Class |
|---|---|
| Ark Biosciences Pty Ltd. | UNKNOWN |
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This study is a phase I, single-center, randomized, double-blind, placebo-controlled study of AK0406 as a first-in-human (FIH) trial to evaluate the safety, tolerability and pharmacokinetics (PK) of AK0406 in healthy adult participants.
This study consists of four cohorts: Cohort A: 150 milligram (mg) subcutaneous injection (s.c.) Cohort B: 300 mg s.c. Cohort C: 600 mg s.c. Cohort D: 900 mg s.c. Each cohort will enroll 8 healthy adult participants (AK0406: placebo = 3: 1), including both females and males. Dose escalation will follow a sequential order, beginning with the lowest dose 150 mg and proceeding to 300 mg, 600 mg, and finally 900 mg. A sentinel-dosing strategy will be implemented. For the first cohort (Cohort A) and the last cohort (Cohort D): the first two participants (1 AK0406, 1 placebo) will be dosed and observed for at least 7 days. The first two participants (1 AK0406, 1 placebo) in Cohort B and Cohort C will be dosed and observed for over 48 hours. After both the investigator and sponsor agree with the acceptable safety and tolerability profile, the remaining 6 participants (5 AK0406, 1 placebo) in that cohort will be dosed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: AK0406 150 mg | Experimental |
| |
| Cohort B:AK0406 300 mg | Experimental |
| |
| Cohort C:AK0406 600 mg | Experimental |
| |
| Cohort D:AK0406 900 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK0406 150 mg | Drug | Single dose of AK0406 150 mg,subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Capture the incidence and severity of adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 6.0 throughout the study period. | Up to Day 181 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration | Samples will be used to evaluate maximum concentration of AK0406 and zanamivir (if any) in plasma. | Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181 |
| Time to maximum concentration |
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Inclusion Criteria:
Exclusion Criteria:
Diagnostic Assessments
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nora Guo | Contact | 86-21-50681677 | nora.guo@arkbiosciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research | Bayswater | Victoria | 3153 | Australia |
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This study consists of four cohorts: Cohort A: 150 milligram (mg) subcutaneous injection (s.c.) Cohort B: 300 mg s.c. Cohort C: 600 mg s.c. Cohort D: 900 mg s.c. Each cohort will enroll 8 healthy adult participants (AK0406: placebo = 3: 1), including both females and males.
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| AK0406 300 mg |
| Drug |
Single dose of AK0406 300 mg,subcutaneous injection |
|
| AK0406 600 mg | Drug | Single dose of AK0406 600 mg,subcutaneous injection |
|
| AK0406 900 mg | Drug | Single dose of AK0406 900 mg,subcutaneous injection |
|
| 0.9% Sodium Chloride Injection as Placebo | Drug | 0.9% Sodium Chloride Injection, subcutaneous injection |
|
Samples will be used to evaluate time to maximum concentration of AK0406 and zanamivir (if any) in plasma. |
| Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181 |
| Area under the drug concentration-time curve from time 0 to the last measurable concentration | Samples will be used to evaluate area under the drug concentration-time curve from time 0 to the last measurable concentration of AK0406 and zanamivir (if any) in plasma. | Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181 |
| Area under the drug concentration-time curve from time 0 to extrapolated to infinite time | Samples will be used to evaluate area under the drug concentration-time curve from time 0 to extrapolated to infinite time of AK0406 and zanamivir (if any) in plasma. | Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181 |
| Terminal half-life | Samples will be used to evaluate terminal half-life of AK0406 and zanamivir (if any) in plasma. | Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181 |
| Apparent clearance | Samples will be used to evaluate apparent clearance of AK0406 and zanamivir (if any) in plasma. | Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181 |
| Apparent volume of distribution | Samples will be used to evaluate apparent volume of distribution of AK0406 and zanamivir (if any) in plasma. | Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181 |
| Incidence and titer of anti-drug antibodies | Incidence and titer of anti-drug antibodies against AK0406 detected in serum. | Baseline, Day 15, Day 31, Day 91, Day 181 |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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