Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958
CS-8958 - A Phase I, Double-blind, Placebo-controlled, Ascending, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects.
Study Overview
Detailed Description
Influenza is an acute febrile illness caused by influenza A and B virus affecting all age groups.Influenza occurs annually and each year it is estimated that influenza epidemics cause 36,000 deaths and 114,000 hospitalizations in the US alone. Control of human influenza virus infections continues to be a major public health goal.Influenza infects the respiratory tract with a rapid onset of symptoms typically characterized by fever, chills, myalgia, headache, malaise, sore throat and cough. Influenza infections are generally self-limiting; however significant morbidity and mortality can occur, predominantly in high risk groups such as the elderly and those suffering from chronic conditions. It is the objective of this clinical trial to investigate safety and tolerability of multiple doses of CS-8958 administered via inhalation in healthy adult subjects. The pharmacokinetics required for this dosing regimen is only achievable by inhalation delivery. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. The primary objective is to evaluate the safety and tolerability of 40mg CS-8958 once or twice a week (on consecutive days) for 6 weeks in healthy adult subjects after multiple doses administered via inhalation. The secondary objective is to assess the systemic exposure of CS-8958 and its active metabolite R-125489 after single and multiple doses of CS-8958 in healthy adult subjects.
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.
Adverse events will be recorded at every visit. Vital signs including blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin will be measured on admission, pre-dose and at multiple time points post each dose. ECGs will be performed on admission, pre-dose and at multiple time points post each dose.Continuous cardiac telemetry will be performed for 24 hours post first dose each week for cohort A and 60 hours post first dose each week for cohort B. Spirometry assessments including forced vital capacity, forced expiratory volume in 1 second, forced expiratory volume percentage in 1 second, forced expiratory flow rate, and peak expiratory flow rate will be performed on admission, pre-dose and at multiple time points post dose. Physical examinations will be performed on Day -1 and at the final visit (and as needed if subject develops symptomatology). Blood samples for hematology and biochemistry assessments will be taken on admission, and 24 hours post dose each week. Urine samples for urinalysis tests will be collected on admission, and 24 hours post dose each week. Blood samples for pharmacokinetic testing will be taken pre-dose and at multiple time points post each dose.
The Safety Monitoring Committee (SMC) will review the safety, tolerability and pharmacokinetic data from Cohort A prior to beginning Cohort B.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Leeds, United Kingdom
- Covance Clinical Research Unit Limited
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: placebo
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Inhaled placebo
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Experimental: CS-8958 DPI
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Inhaled CS-8958
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
Time Frame: Duration of study
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Duration of study
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Collaborators and Investigators
Investigators
- Principal Investigator: Jane Ryan, PhD, Biota Scientific Management Pty Ltd
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-0002 (Other Grant/Funding Number: NIAID DMID)
- 1UC1AI062373-01 (U.S. NIH Grant/Contract)
- 2008-000911-14 (EudraCT Number)
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