Phase 1 Safety and Pharmacokinetics Study of Single 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

NCT02558413

BTA585-001

Details and patient eligibility

About

This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women aged 18-60 years;
• Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32;
• Female subjects must be of non-childbearing potential;
• Male subjects must agree to use a double barrier method of birth control;
• Able to provide informed consent

Exclusion criteria

• Current or recent (within 14 days of Day 0) bacterial or viral infection;
• Positive results for hepatitis B, hepatitis C, or HIV;
• Clinically significant abnormalities noted on ECG;
• Safety laboratory abnormalities;
• Regular use of medications, prescription or non-prescription;
• Poor vein access or fear of venipuncture;
• Major surgery, significant recent injury or trauma within 30 days;
• 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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60 participants in 2 patient groups, including a placebo group

BTA-C585 oral capsules

Active Comparator group

Description:

25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 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