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

NCT ID: NCT02668367

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-02-29

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.

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

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

Group Type: ACTIVE_COMPARATOR

BTA-C585 oral capsules

Intervention Type: DRUG

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

BTA-C585 matching placebo

BTA-C585 Matching placebo capsules; single doses

Group Type: PLACEBO_COMPARATOR

BTA-C585 matching placebo

Intervention Type: DRUG

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

Interventions

BTA-C585 oral capsules

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

Intervention Type: DRUG

BTA-C585 matching placebo

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

Intervention Type: DRUG

Other Intervention Names

BTA585; BTA585

Eligibility Criteria

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.

• 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

BTA585-002

Identifier Type: -

Identifier Source: org_study_id