Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Healthy VolunteersBacterial Infections
Interventions
DRUG

RPX7009

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

DRUG

RPX2014

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

DRUG

Placebo

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

DRUG

Combination RPX7009 and RPX2014

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Trial Locations (1)

5000

CMAX, Adelaide

All Listed Sponsors
lead

Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

INDUSTRY

NCT01897779 - Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects | Biotech Hunter | Biotech Hunter