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

Pulmocide

Status and phase

Completed

Phase 2

Phase 1

Conditions

Respiratory Syncytial Virus Infections

Treatments

Drug: PC786

Drug: Placebo/vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT03382431

PC_RSV_003

2017-002563-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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