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

Biota Pharmaceuticals, Inc.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pharmacokinetics Healthy Volunteers

Interventions

BTA-C585 oral capsulesDRUG

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

BTA-C585 matching placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Biota Investigational Site

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Number of adverse events

Time frame: Day 0 to Day 11

Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours

Time frame: 0-24 hours

Data from ClinicalTrials.gov

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