MedTrace Logo

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

NCT01803308 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-09-18

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • F-star Therapeutics, Inc.

    collaborator INDUSTRY

  • Syneos Health

    lead OTHER

Principal Investigators

  • Donald Mitchell · F-star Therapeutics, Inc.

  • Alexander Thompson, MD, PhD · Nucleus Network, The Alfred Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01803308 on ClinicalTrials.gov