Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers

A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02668367

Enrollment

Registered

2016-01-29

Start date

2015-11-30

Completion date

2016-02-29

Last updated

2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Pharmacokinetics

Keywords

Viral Diseases, Antiviral, Paramyxoviridae Infections, RSV, Respiratory Syncytial Virus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen

Brief summary

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

Interventions

DRUGBTA-C585 oral capsules

BTA-C585; Multiple ascending doses from 100 mg to 600 mg

DRUGBTA-C585 matching placebo

Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy men and women; 2. Age 18 to 60 years, inclusive; 3. Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive; 4. Female subjects must be of non-childbearing potential; 5. Male subjects must agree to use a double barrier method of birth control; 6. Signed informed consent form (ICF) prior to study procedures.

Exclusion criteria

1. Current or recent (within 14 days of Day 0) bacterial or viral infection; 2. Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody; 3. Clinically significant abnormalities noted on ECG; 4. Safety laboratory abnormalities; 5. Regular use of medications, prescription or non-prescription; 6. Poor vein access or fear of venipuncture or sight of blood; 7. Major surgery, significant recent injury or trauma within 30 days; 8. Received an investigational drug or vaccine within 30 days.

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours	0-24 hours
Number of adverse events	Day -1 to Day 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026