Skip to main content
OpenTrials
Completed

NCT Number: NCT02558413

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetics Healthy Volunteers Infections Mononegavirales Infections Paramyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biota Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTA-C585 oral capsules

Drug

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

Other names: BTA585

BTA-C585 matching placebo

Drug

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

Other names: BTA585

Primary outcomes

  1. Number of adverse events

    Time frame: Day 0 to Day 11

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

    Time frame: 0-24 hours

Sponsors and collaborators

Lead sponsor

Biota Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2015
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.