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This is a placebo-controlled randomized phase 1 study to investigate the safety and pharmacokinetics of DAA-I in a cohort of healthy subjects.
The study will be a single-blind, step-wise dose escalation, placebo controlled study in healthy subjects consisting of up to 3 dose steps of DAA-I. In the sequential step wise design, a single dose of DAA-I or placebo will be administered to 6 subjects for one treatment group. For each dose step, 4 subjects will receive DAA-I and 2 subjects will receive placebo. Subjects will be randomly allocated to one dose step. Step One would have to be completed before Step Two. Escalation up to Step Two and subsequent steps would depend on the safety results from the preceding step(s). There will be an interval of 6 hours between the dosing of the first and second DAA-I-treated volunteers of each cohort to allow for early cardiovascular monitoring. Only if there are no safety signals identify from these subjects as assessed by the Safety Review Committee can simultaneous dosing of the remaining volunteers be carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAA-I 6mg | Experimental | Subjects given solid compound in vials containing 6mg per vial |
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| DAA-I 50mg | Experimental | Subjects given solid compound in vials containing 50mg per vial |
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| DAA-I 110mg | Experimental | Subjects given solid compound in vials containing 110mg per vial |
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| Placebo | Placebo Comparator | Subjects given 25ml placebo dissolved in 200ml water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAA-I | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and dose range of DAA-I after single oral dose administration | Evaluate the safety (in terms of effect on normal blood pressure, pulse, and 12-lead ECG) of DAA-I following a single oral administration in 12 healthy subjects (0.08 mg/kg/subject in 4 subjects, 0.7 mg/kg/subject in 4 subjects, and 1.5 mg/kg/subject in 4 subjects). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics of DAA-I after single oral dose administrations | Evaluate the plasma level of DAA-I in each subject at baseline (0 hr) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, and 12 hr after oral administration of a single-dose of DAA-I, and determine the area under the plasma concentration versus time curve (AUC). | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27681888 | Derived | Lee KO, Khoo CM, Chowbay B, Chan YH, Sim MK. A Single Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Orally Administered Des-Aspartate Angiotensin I in Healthy Subjects. Drugs R D. 2016 Dec;16(4):317-326. doi: 10.1007/s40268-016-0143-y. |
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| Drug |
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