Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802
Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by multiple ascending dose (MAD) cohorts in healthy male and female subjects.
Ebola Virus Infection
Drug: TKM-100802 for Injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study With Additional Multiple-Ascending Dose Cohorts to Evaluate the Safety, Tolerability, and Pharmacokinetics of TKM-100802 in Healthy Human Volunteers|
- Safety and tolerability of TKM-100802 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Subjects will be monitored for treatment-emergent and dose-limiting toxicity (DLT). If there are any adverse events (changes from baseline in laboratory parameters, vitals and/or infusion reactions) during these monitoring periods, the Independent Safety Committee, will discuss the dosing of the remaining subjects.
Before proceeding to the next dose cohort, the Independent Safety Committee will evaluate whether dose escalation will be permitted based on demonstration of adequate safety and tolerability.
- Pharmacokinetics - Cmax, Tmax and AUC [ Time Frame: 1 month ] [ Designated as safety issue: No ]Time-points: Before infusion, mid-point of infusion, end of infusion and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours after end of infusion and day 7, day 10, day 15, day 22 and day 29.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Experimental: TKM-100802 for Injection||
Drug: TKM-100802 for Injection
|Placebo Comparator: Placebo||
Other Name: Normal saline
Approximately 28 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 MAD phase, a dose escalation scheme will be proposed following review of the findings from cohorts 1 to 4 of the SAD phase. The MAD phase is expected to have at least 3 cohorts with 4 subjects (3 receiving TKM-100802 and 1 receiving saline) in each cohort.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02041715
|Contact: Bianca Bourdeau, B.Sc.||email@example.com|
|Contact: Lesley Parker, B.Sc.||firstname.lastname@example.org|
|United States, Texas|
|Healthcare Discoveries, LLC d/b/a ICON Development Solutions||Recruiting|
|San Antonio, Texas, United States, 78209|
|Principal Investigator: Emanuel DeNoia, MD|
|Study Director:||Mark Kowalski, MD||Tekmira Pharmaceuticals Corporation|
|Principal Investigator:||Emanuel DeNoia, MD||ICON Development Solutions|