Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers

BTG International Inc.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Vaccine

Interventions

CoVaccine HTBIOLOGICAL

intramuscular injection, dose escalation

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quintiles Drug Research Unit

London, United Kingdom

Outcomes

Primary Outcomes

Safety Events

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 Participants were withdrawn upon experiencing any adverse event.

Time frame: Duration of study

Data from ClinicalTrials.gov

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