Status:
COMPLETED
A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
Lead Sponsor:
Pulmocide Ltd
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
PC786 is a new medicine being developed for treatment of respiratory syncytial virus. The main purpose of this study is to evaluate the antiviral activity of PC786 in healthy adults infected with RSV ...
Eligibility Criteria
Inclusion
- Subject is in good health as determined by the Investigator based on medical history, physical examination, and routine laboratory tests at a screening evaluation.
- Male or female, aged between 18 and 55 years inclusive
- Body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 30kg/m2
- Subject must provide written informed consent
- Serosuitable to the challenge virus.
Exclusion
- History or evidence of any clinically significant or currently active major clinical illness.
- Any significant abnormality altering the anatomy of the nose or nasopharynx
- Any nasal or sinus surgery within six months of the study
- Abnormal lung function
- Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.
- Presence of cold like symptoms and/or fever on admission for the study
- History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks of the study
- History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03382431
Start Date
November 14 2017
End Date
May 9 2018
Last Update
May 16 2018
Active Locations (1)
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1
hVIVO Services Ltd
London, United Kingdom, E1 2AX