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

Pulmocide Ltd56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Respiratory Syncytial Virus Infections

Interventions

PC786DRUG

Repeat doses

Placebo/vehicleDRUG

Repeat doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

hVIVO Services Ltd

London, United Kingdom

Outcomes

Primary Outcomes

RSV viral load

AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR)

Time frame: Baseline to Day 28