Completed

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

What is being tested

SB9200

+ SB9200

+ Placebo

Drug

Who is being recruted

Blood-Borne Infections+19

+ Organizing Pneumonia

+ Bronchial Diseases

From 18 to 60 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorSyneos Health

Last updated: September 18, 2019

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01803308

Principal SponsorSyneos Health

Last updated: September 18, 2019

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

37 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsOrganizing PneumoniaBronchial DiseasesBronchiolitisBronchiolitis ObliteransBronchitisCommunicable DiseasesDigestive System DiseasesGraft vs Host DiseaseHepatitisHepatitis, Viral, HumanImmune System DiseasesInfectionsLiver DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory Tract DiseasesRNA Virus InfectionsVirus DiseasesFlaviviridae InfectionsBronchiolitis Obliterans SyndromeHepatitis C

Criteria

12 inclusion criteria required to participate

Males or females of non-childbearing potential between the ages of 18 and 60 years, inclusive

Must be able to communicate with site personnel and understand instructions

Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Must have HCV and laboratory evidence of HCV infection for at least six months before the Screening Visit

Show More Criteria

16 exclusion criteria prevent from participating

Any condition possibly affecting drug absorption (e.g., gastrectomy)

Any other cause of significant liver disease in addition to HCV, which may include, but is not limited to, malignancy with hepatic involvement, hepatitis B, drug or alcohol related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, or primary biliary cirrhosis

Any other medical or psychiatric condition or laboratory abnormality which, in the view of the Investigator, is likely to interfere with the study or put the subject at risk

Any previous treatment with an investigational or approved drug or drug regimen for the treatment of HCV. Note: SB 9200 is excluded from this criterion, i.e. subjects who complete Part A of the study will be eligible to participate in Part B of the study

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Experimental: Part A: Part A will use a single ascending dose protocol in small, open-label cohorts to determine the starting dose for Part B in the potentially therapeutic range. Intervention: SB9200

Group II

Experimental

Experimental: Part B: Part B will use a multiple ascending dose protocol to further explore the safety, tolerability, pharmacokinetics and pharmacodynamics of SB9200 over 7-14 days of dosing. Intervention: SB9200 and Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Nucleus Network, Austin Hospital

Heidelberg, AustraliaOpen Nucleus Network, Austin Hospital in Google Maps

Nucleus Network, The Alfred Hospital

Melbourne, Australia

Linear Clinical Research, The Queen Elizabeth II Medical Centre

Nedlands, Australia

Primorus Clinical Trials Ltd

Christchurch, New Zealand

Completed4 Study Centers