Hereditary Angioedema Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BCX7353 in Healthy Subjects
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have in the body.
Up to 6 ascending, single dose cohorts are planned to be dosed in a sequential manner in
Part 1 of the study. Eight subjects will be treated with a single dose of study drug per
dose cohort (6 subjects per cohort will receive BCX7353 and 2 subjects per cohort will
receive matching placebo). Escalation to the next higher dose level will occur only after
completion of a review of clinical safety and pharmacokinetics by the Sponsor and PI.
Up to 4 ascending, multiple dose cohorts will be enrolled in a sequential manner in Part 2
of the study. Twelve subjects will be treated with study drug per dose cohort (10 subjects
will receive BCX7353 and 2 subjects will receive placebo per cohort). The planned doses,
dosing regimens, and duration of dosing (7 or 14 days) for each of the Part 2 cohorts will
be determined based upon safety and pharmacokinetic data collected during the study.
Escalation to the next higher dose level in Part 2 will occur only after completion of a
review of clinical safety and pharmacokinetics by the Sponsor and clinical site study
physician.
In Part 3 of the study, the safety, tolerability, PK, and PD of single and multiple doses of
oral BCX7353 versus placebo in healthy subjects of Japanese origin will be evaluated. In the
single dose cohort, 16 Japanese subjects will be randomized into a single cohort to receive
either placebo or 1 of 2 active doses of BCX7353. In the multiple dose cohort, twelve
subjects will be treated with study drug (10 subjects will receive BCX7353 and 2 subjects
will receive placebo per cohort). The planned doses (single and multiple dose cohort), and
dosing regimen and duration of dosing (7 or 14 days; multple dose cohort) for Part 3 will be
determined based upon safety and pharmacokinetic data collected during Parts 1 and 2 of the
study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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