Intravenous (IV) Administration of Cempra Pharmaceutical's Solithromycin (CEM-101) Demonstrates Excellent Systemic Tolerability in a Phase 1 Clinical Trial
CHAPEL HILL, N.C., May 7, 2011 /PRNewswire/ -- Cempra Pharmaceuticals, a developer of differentiated antibiotics, today announced an oral presentation showing that intravenous (IV) solithromycin demonstrates excellent tolerability and a favorable pharmacokinetic (PK) profile at IV doses up to 800 mg. Oral administration of solithromycin also showed excellent tolerability in previously reported Phase 1 studies. The presentation will be at the 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)/27th International Congress of Chemotherapy (ICC), May 7 to 10, 2011, in Milan, Italy. Cempra will also present additional in vitro activity data on both of the company's clinical candidates, solithromycin and TAKSTA (CEM-102 or fusidic acid).
Solithromycin IV Phase 1 Study
The Phase 1 study (Abstract O-95) was a single-center, randomized, double-blind, placebo-controlled dose-escalation study in healthy volunteers. Forty-two subjects were enrolled in the single ascending dose portion of the study and divided into seven dose cohorts of 25, 50, 100, 200, 400 and 800 mg of solithromycin and placebo. Subjects were monitored for 48 hours post-dose for safety and PK assessments.
There were no serious adverse events or clinically significant laboratory abnormalities. The drug candidate demonstrated a favorable PK profile in single doses up to 800 mg and achieved clinically relevant plasma concentrations of about 4 micrograms/mL. Intravenous exposure was 1.3 to three fold higher than that observed with equivalent oral doses.
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