Safety Study of Ch-mAb7F9 for Methamphetamine Abuse
Biological: normal saline
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase Ia, Double-blind, Randomized, Placebo-controlled, Ascending IV Single-dose Study to Evaluate the Safety and Pharmacokinetics of ch mAb7F9 in Healthy Subjects|
- Safety [ Time Frame: 21 weeks ]The primary outcome is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.
- Pharmacokinetics [ Time Frame: 21 weeks ]A secondary outcome is to characterize the pharmacokinetics of ch-mAb7F9 following single, ascending intravenous doses of ch-mAb7F9 in healthy subjects by measurement of mAb serum concentrations
- Immunogenicity [ Time Frame: 21 weeks ]A secondary outcome is to characterize the immune response following single, ascending intravenous doses of ch-mAb7F9 in healthy subjects by measurement of human anti-ch-mAb7F9 antibody (HACA) serum titers.
|Study Start Date:||April 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Saline
A total of 10 subjects will receive placebo
Biological: normal saline
saline 225 ml
The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively.
The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Volume to be administered 225 ml
There will be 5 dose groups. At the beginning of dosing in each group, 1 subject will receive the normal saline placebo and 1 will receive the active dose. The remainder of the dose group will receive their doses beginning 48 hr later, after safety evaluations. Dosing of the remaining subjects in each dose group will occur 1 at a time, with dosing in each subsequent subject separated by a minimum of 24 hr. Subsequent dose groups will receive their doses beginning approximately 2 weeks after dosing in the preceding group, pending safety analyses.
The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. The starting dose will be 0.2 mg/kg, and the highest dose will be 20 mg/kg (up to a maximum of 1,500 mg), which is at least 20-fold lower than the no observable adverse effect level (NOAEL) in rats to ensure subject safety.
Ch-mAb7F9 will be administered intravenously (IV) with a saline flush to clear the administration tubing of residual ch-mAb7F9. Each dose of ch-mAb7F9 will be diluted in 225 ml of saline and given over two hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603147
|United States, Kansas|
|Quintiles Phase 1 Services|
|Overland Park, Kansas, United States, 66211|