A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers

BTG International Inc.1 site in 1 country50 target enrollmentNovember 2009

ConditionsVaccine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Vaccine
Sponsor: BTG International Inc.
Enrollment: 50
Locations: 1
Primary Endpoint: Safety Events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

June 2010

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BTG International Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI)
•Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG.
•Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission.

Exclusion Criteria

•History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption.
•Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing
•Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis

Outcomes

Primary Outcomes

Safety Events

Time Frame: Duration of study

Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.