An Exploratory Open-Label Oligo-Center Study to Evaluate the Safety Efficacy and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile Infection

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Deinove
Updated on 21 April 2021

Summary

This is an open-label study to evaluate the safety, efficacy, and PK of DNV3837 at a dose of 1.5 mg/kg actual body weight(BW)/day administered via IV infusion in subjects with CDI. The study will be conducted in 2 subsequent parts. In Part 1 of the study, 10 subjects of either sex with non-severe CDI will be enrolled to receive DNV3837. In Part 2 of the study, up to 30 subjects with severe CDI will be enrolled and randomized in a 2:1 ratio to receive DNV3837 or SOC.

In both parts of the study, treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total daily dose of 120 mg DNV3837. Infusions will be administered once daily for 10 consecutive days. The objectives of the study are:

  • To evaluate the safety of intravenous (IV) DNV3837;
  • To evaluate the efficacy of IV DNV3837 versus standard of care (SOC);
  • To assess the pharmacokinetics (PK) of DNV3837 and DNV3681 in plasma and of DNV3681 in urine and feces;
  • To assess C. difficile using microbiological assessments;
  • To assess the proportion of subjects colonized with vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase (ESBL) organisms, or carbapenem-resistant Enterobacteriaceae (CRE) in feces; and
  • To assess changes in the fecal microbiome using 16S ribosomal ribonucleic acid (RNA) analysis

Details
Condition Clostridium difficile
Treatment Standard of Care, DNV3837
Clinical Study IdentifierNCT03988855
SponsorDeinove
Last Modified on21 April 2021

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