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Completed

NCT Number: NCT02668367

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

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

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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;
  • Age 18 to 60 years, inclusive;
  • Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;
  • Female subjects must be of non-childbearing potential;
  • Male subjects must agree to use a double barrier method of birth control;
  • Signed informed consent form (ICF) prior to study procedures.

Exclusion criteria

  • Current or recent (within 14 days of Day 0) bacterial or viral infection;
  • Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;
  • Clinically significant abnormalities noted on ECG;
  • Safety laboratory abnormalities;
  • Regular use of medications, prescription or non-prescription;
  • Poor vein access or fear of venipuncture or sight of blood;
  • 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; Multiple ascending doses from 100 mg to 600 mg

Other names: BTA585

BTA-C585 matching placebo

Drug

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

Other names: BTA585

Primary outcomes

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

    Time frame: 0-24 hours

  2. Number of adverse events

    Time frame: Day -1 to Day 14

Sponsors and collaborators

Lead sponsor

Biota Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
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.

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