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AK3280 is being developed to further improve the long-term efficacy and tolerability of treatment options for patients with fibrotic disorders.This study will evaluate the effect of AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK3280 (Cohort 1) | Experimental | Subjects in Cohort 1 are administered with an oral dose of 100 mg AK3280 b.i.d from Day 1 to Day 14. |
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| AK3280 (Cohort 2) | Experimental | Subjects in Cohort 2 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 2 will be based on the emerging data from previous cohort. |
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| AK3280 (Cohort 3) | Experimental | Subjects in Cohort 3 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 3 will be based on the emerging data from previous cohorts. |
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| Placebo | Placebo Comparator | For assessment of the Adverse Event (AE) profile, there are placebo controls in each dose cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK3280 | Drug | Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Directly measured absolute glomerular filtration rate (mGFR) results. | The effect of AK3280 treatment on GFR is measured by iohexol plasma clearance. | Days -1, 7, and 14. |
| Change from baseline mGFR results. | To compare the difference of effect of AK3280 treatment on GFR. | Days 7 and 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency, intensity, and seriousness of Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormal safety laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | From Day -1 to Day 28. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jimmy Gu | info@arkbiosciences.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTC Clinical Trial Consultants AB | Uppsala | Sweden |
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| Placebo | Drug | Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral |
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| Change in blood renal function biomarkers |
Blood renal function biomarkers include cystatin C, beta-trace protein, p-myoglobin, etc. |
| Screening, Days -2, 7, 14, and 21. |
| Change in urine renal function biomarkers | Urine renal function biomarkers include electrolytes, albumin, alpha1-microglobulin, etc. | From Day -1 to Day 21. |
| Maximum Observed Plasma Concentration (Cmax) | The maximum observed plasma concentration of AK3280 and its major metabolite, AK3280-M2. | Days 1, 7, and 14. |
| Concentration at the end of the dosing interval (Ctau) | The concentration of AK3280 and its major metabolite, AK3280-M2, at the end of the dosing interval. | Days 1, 7, and 14. |
| trough plasma concentration (Ctrough) | The trough observed plasma concentration of AK3280 and its major metabolite, AK3280-M2. | Days 1, 7 and 14. |
| trough plasma concentration (Ctrough) | The trough observed plasma concentration of AK3280 and its major metabolite, AK3280-M2. | Days 1, 7, and 14. |
| Area under the plasma concentration-time curve from time zero up to time (AUC 0-t) | The area under the plasma concentration-time curve from time zero up to the last analytically quantifiable concentration of AK3280. | Days 1, 7, and 14. |