Drug Safety Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CARD-024 (1α-Hydroxy-Vitamin-D5) in Healthy Subjects
Study Phase: Phase 1
Primary Objective:
• To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in
healthy subjects
Secondary Objectives:
- To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single
oral doses of CARD-024
- To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin
activity (PRA) and blood pressure (BP), biological markers of activity, following
ascending single oral doses of CARD-024
Study Design: This is a single-center, double-blind, randomized, placebo-controlled study of
single oral doses of CARD-024. Four planned cohorts of 8 subjects each will be dosed
sequentially and randomized to receive a single dose of active drug (6 subjects) or placebo
(2 subjects). Cohort 4 will have 10 subjects randomized to receive active drug (7 subjects)
or placebo (3 subjects). Each cohort will be divided into at least 2 groups; the first group
will have 2 subjects, 1 receiving active drug and 1 receiving placebo. Dosing of the
remaining 6 subjects in each cohort will be completed in a manner agreed upon by the Sponsor
and the Principal Investigator in keeping with the randomization schedule and blinded
conditions.
The planned cohorts are:
Cohort CARD-024 Dose*
1. 3 μg
2. 9 μg
3. 27 μg
4. 81 μg
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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