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

Biota Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Pharmacokinetics

Treatments: Drug: BTA-C585 oral capsules; Drug: BTA-C585 matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02668367

BTA585-002

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

BTA-C585 oral capsules

Active Comparator group

Description:

100 mg capsules; Multiple ascending doses (MAD) from 100 mg to 600 mg

Treatment:

Drug: BTA-C585 oral capsules

BTA-C585 matching placebo

Placebo Comparator group

Description:

BTA-C585 Matching placebo capsules; single doses

Treatment:

Drug: BTA-C585 matching placebo