Finding studies
Finding studies
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Lead
Kashiv BioSciences, LLC
Single ascending dose (SAD) of four cohorts (01, 02, 03, and 04) for the test product (25, 100, 250, and 500 mg, respectively). Subjects who will participate in cohort no. 01 (N= 18 subjects) will be randomized to receive a single dose of the test product 25 mg (N= 10 subjects) or a single dose of the reference product 500 mg (N= 08 subjects). The randomization ratio will be 5:4 for T: R Study Part II: Multiple doses of three treatment arms will be administered in one cohort (N= 32, parallel design). • Two treatment arms of the test product: T1: the dose lower than maximum tolerated dose (MTD-1) determined in Study Part I, N=12 subjects. T2: maximum tolerated dose determined in Study Part I, N=12 subjects. • One treatment arm of the reference product: R: 500 mg, N= 08 subjects The randomization ratio will be 3:3:2 for T1:T2: R\]
Age
40–60
Sex
FEMALE
Healthy volunteers
Accepted
