Healthy Volunteers, Pharmacokinetics
Conditions
Keywords
Viral Diseases, Antiviral, Paramyxoviridae Infections, RSV, Respiratory Syncytial Virus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
Brief summary
This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.
Interventions
BTA-C585; Single ascending doses from 50 mg to 800 mg
Single ascending doses to match 50 to 800 mg BTA-C585 capsules
Sponsors
Biota Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women aged 18-60 years; * Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32; * Female subjects must be of non-childbearing potential; * Male subjects must agree to use a double barrier method of birth control; * Able to provide informed consent
Exclusion criteria
* Current or recent (within 14 days of Day 0) bacterial or viral infection; * Positive results for hepatitis B, hepatitis C, or HIV; * Clinically significant abnormalities noted on ECG; * Safety laboratory abnormalities; * Regular use of medications, prescription or non-prescription; * Poor vein access or fear of venipuncture; * Major surgery, significant recent injury or trauma within 30 days; * Received an investigational drug or vaccine within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | Day 0 to Day 11 |
| Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours | 0-24 hours |
Countries
United States
Outcome results
None listed