NCT01603147

Safety Study of Ch-mAb7F9 for Methamphetamine Abuse

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: InterveXion Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective 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.Phase 1a, randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive a single dose of ch-mAb7F9 or placebo (saline).

Detailed description

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.

Conditions

• Methamphetamine Abuse

Interventions

Type	Name	Description
BIOLOGICAL	normal saline	saline 225 ml
BIOLOGICAL	ch-mAb7f9	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

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-05-22
• Last updated: 2014-05-13

Locations

1 site across 1 country: United States