A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study

• Status: Completed
• Trial end date: 2018-05-09
• Target enrollment: 0
• Participant gender: All

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 virus in a viral challenge study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pulmocide Ltd
• Treatments: PC-786

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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