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Phase I Trial to Determine the Safety and Pharmacokinetics of CRS3123.

2014-09-25 15:08:22 | BioPortfolio

Summary

This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple ascending dose study to evaluate the safety and tolerability of CRS3123, a methionyl-tRNA synthetase inhibitor. In this study, doses of 200, 400, and 600 mg, or 100mg are planned and will be given orally every 12 hours for 10 days. Up to 30 healthy male and female subjects 18 to 45 years, inclusive. The primary objective: of the study is to determine the safety and tolerability of escalating doses of CRS3123 following oral administration of multiple doses to healthy adults. The study duration is 46 weeks.

Description

This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple ascending dose study to evaluate the safety and tolerability of CRS3123, a methionyl-tRNA synthetase inhibitor. In this study, doses of 200, 400, and 600 mg, or 100mg are planned and will be given orally every 12 hours for 10 days. Therefore, there is a possibility of clinically significant absorption of study drug. If any significant safety signals (See Section 8.5.3 Halting Rules) are encountered, the investigators will notify DMID who will determine the need for an ad hoc SMC review. For the purposes of this study, "Ad hoc" simply means unscheduled which may be held at any time throughout the study per DMID's discretion. If deemed appropriate by halting rules and/or DMID's discretion enrollment will be halted for an ad hoc SMC meeting. Decision to resume the study after halting will be determined by DMID in consideration of the SMC recommendations. The dose for Cohort B and study progression and dose escalation to Cohorts B and C will require a full (planned) SMC review of all safety data obtained through Day 18. Should safety data review of the 200 mg dose result in an unfavorable safety profile, the study design allows for reduction in dose to 100 mg to be given in Cohort B. If this is the case, there will be no Cohort C. Each subject will receive oral doses of CRS3123 or placebo. Up to 30 healthy male and female subjects 18 to 45 years, inclusive. The primary objective: of the study is to determine the safety and tolerability of escalating doses of CRS3123 following oral administration of multiple doses to healthy adults. The study duration is 46 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Clostridial Infection

Intervention

CRS3123, Placebo

Location

Quintiles Phase I Services - Overland Park
Overland Park
Kansas
United States
66211-1553

Status

Recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-25T15:08:22-0400

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