NCT01803308

A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection

A Phase 1a/1b Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SB 9200 in Treatment Naïve HCV Infected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and tolerability of ascending doses of SB 9200 given for up to 14 days to subjects with chronic Hepatitis C infection.

Detailed description

This is a First-in-human, Two-stage, Multi-centre study. Part A is an open-label, single ascending dose study in fed or fasted subjects and Part B is a randomized, placebo-controlled multiple ascending dose study. The study is designed to evaluate the safety and tolerability of ascending doses of SB 9200 given as monotherapy for up to 14 days to subjects with chronic Hepatitis C infection, and to determine the pharmacokinetic and pharmacodynamic relationship over this dose range.

Conditions

• Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	SB9200	Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.
DRUG	SB9200	Part B randomised 6:2 (active:placebo) using recommended Part B starting dose, and ascending to up to 1500mg for 7-14 days of dosing.
DRUG	Placebo	Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-03-04
• Last updated: 2019-09-18

Locations

4 sites across 2 countries: Australia, New Zealand