Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Healthy VolunteersBacterial Infections
Interventions
DRUG

RPX2003 (Biapenem)

"Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation.~Single dose followed by multiple dose, three times a day."

DRUG

Placebo

"Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation.~Single dose followed by multiple dose, three times a day."

Trial Locations (1)

85283

Celerion, Tempe

All Listed Sponsors
lead

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

INDUSTRY

NCT01702649 - Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects | Biotech Hunter | Biotech Hunter