Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers

NCT ID: NCT02558413

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Pharmacokinetics; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BTA-C585 oral capsules

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

Group Type: ACTIVE_COMPARATOR

BTA-C585 oral capsules

Intervention Type: DRUG

BTA-C585; Single ascending doses from 50 mg to 800 mg

BTA-C585 matching placebo

BTA-C585 Matching placebo capsules; single doses

Group Type: PLACEBO_COMPARATOR

BTA-C585 matching placebo

Intervention Type: DRUG

Single ascending doses to match 50 to 800 mg BTA-C585 capsules

Interventions

BTA-C585 oral capsules

BTA-C585; Single ascending doses from 50 mg to 800 mg

Intervention Type: DRUG

BTA-C585 matching placebo

Single ascending doses to match 50 to 800 mg BTA-C585 capsules

Intervention Type: DRUG

Other Intervention Names

BTA585; BTA585

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biota Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Novotney-Barry

Role: STUDY_DIRECTOR

Biota Pharmaceuticals, Inc.

Locations

Biota Investigational Site

San Antonio, Texas, United States

Countries

United States

Other Identifiers

BTA585-001

Identifier Type: -

Identifier Source: org_study_id