Influenza Clinical Trial
Official title:
CS-8958 - A Phase I, Double-blind, Placebo-controlled, Ascending, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects.
Verified date | May 2018 |
Source | Vaxart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test the safety and tolerability of an investigational multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. Participants will be divided into two treatment groups (Groups A and B) with each group consisting of 8 subjects. Participants will be involved in study related procedures for a maximum of 14 weeks from initial screen to the follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two subjects will receive placebo (substance containing no medication), once a week for six weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects will receive placebo, twice a week for six weeks. Study procedures will include blood and urine samples, ECGs (measure of heart activity), blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin. Also continuous cardiac telemetry will be performed as well as physical examinations and spirometry assessments.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Male and Female subjects aged 18 to 55 years, inclusive Exclusion Criteria: - Pregnant or lactating female subjects. - Out of range findings in vital signs, physical examination, or lab tests. - Intake of any investigational drug within the 4 months prior to Day 0. - Positive urine drug screen or alcohol breath test. - Significant disease, event, or condition which may impact on subject safety or study compliance. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Covance Clinical Research Unit Limited | Leeds |
Lead Sponsor | Collaborator |
---|---|
Biota Scientific Management Pty Ltd | National Institute of Allergy and Infectious Diseases (NIAID) |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability will be assessed via occurrences of treatment-emergent adverse events, changes in vital signs including BP, PR, SpO2, temperature, ECG, spirometry, physical examinations, and laboratory parameters | Duration of study |
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