NCT01803308View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Hepatitis C Infection
Interventions
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.

Trial Locations (4)

3004

Nucleus Network, The Alfred Hospital, Melbourne

3084

Nucleus Network, Austin Hospital, Heidelberg

6009

Linear Clinical Research, The Queen Elizabeth II Medical Centre, Nedlands

8011

Primorus Clinical Trials Ltd, Christchurch

Sponsors

Lead Sponsor

Syneos Health

Collaborators (1)

F-star Therapeutics, Inc.
All Listed Sponsors
collaborator

F-star Therapeutics, Inc.

INDUSTRY

lead

Syneos Health

OTHER

NCT01803308 - A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection | Biotech Hunter | Biotech Hunter