Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study

Biota Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus (RSV) Infection

Treatments: Drug: BTA-C585 oral capsule; Drug: Matching placebo capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02718937

BTA585-003

Details and patient eligibility

About

The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female
2. Between 18 to 50 years old
3. Body mass index of 18 to 30 kg/m2

Exclusion criteria

1. Acute or chronic medical illness
2. Abnormal lung function Positive for HIV, Hepatitis B or C
3. Any significant abnormality of the nose or nasopharynx

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

BTA-C585

Experimental group

Description:

BTA-C585 100 mg oral capsule

Treatment:

Drug: BTA-C585 oral capsule

Placebo

Placebo Comparator group

Description:

Matching placebo capsule

Treatment:

Drug: Matching placebo capsules