Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study of Intravenous (IV) TKM-100201 Infusion
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|ClinicalTrials.gov Identifier: NCT01518881|
Recruitment Status : Terminated (Corporate decision to reformulate the investigational product.)
First Posted : January 26, 2012
Last Update Posted : January 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ebola Virus Infection||Drug: TKM-100201 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|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-100201 in Healthy Human Volunteers|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Other Name: TKM-Ebola
|Placebo Comparator: Placebo||
Other Name: Normal Saline
- Safety and Tolerability of Treatment with TKM-100201 [ Time Frame: 1 month ]
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 will be calculated [ Time Frame: 29 days post infusion ]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, 48 hours after infusion and day 7, day 10, day 15, day 22 and day 29.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518881
|United States, North Dakota|
|Fargo, North Dakota, United States, 58104|
|Principal Investigator:||Gregory M Haugen, M.D.||Cetero Research, San Antonio|