NCT03354754

LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)

A Randomized, Controlled, Evaluator-blinded, Multi-center Study to Evaluate LYS228 Pharmacokinetics, Clinical Response, Safety, and Tolerability in Patients With Complicated Intra-abdominal Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections. It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed. PK analysis was not conducted as per protocol the first analysis required 8 patients.

Conditions

• Intra-abdominal Infections

Interventions

Type	Name	Description
DRUG	LYS228	LYS228 IV infusion every 6 hours
DRUG	Standard of care therapy	IV infusion of standard of care antibiotics

Timeline

• Start date: 2018-05-15
• Primary completion: 2018-09-24
• Completion: 2018-09-24
• First posted: 2017-11-28
• Last updated: 2021-10-11
• Results posted: 2019-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study