Ebola Virus Infection Clinical Trial
Official title:
A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study With An Additional Multiple-Dose Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TKM-100802 in Healthy Human Volunteers
Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.
Approximately 20 male and female healthy adult subjects, 18 to 50 years of age at the time of dosing, will participate in this study. The SAD phase of the study is planned to have up to 4 cohorts with 4 subjects (3 receiving TKM-100802 and 1 receiving saline) in each cohort. Additional cohorts may be enrolled in the SAD phase if a MTD is not established after the initial 4 cohorts. In the multiple-dose phase, one cohort is planned with 4 subjects (3 receiving TKM-100802 and 1 receiving saline) at a maximum dose of 0.24 mg/kg TKM-100802. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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