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

Sponsor
Biota Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02558413
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
4
Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BTA-C585 oral capsules
  • Drug: BTA-C585 matching placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BTA-C585 oral capsules

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

Drug: BTA-C585 oral capsules
BTA-C585; Single ascending doses from 50 mg to 800 mg
Other Names:
  • BTA585

    		•
    Placebo Comparator: BTA-C585 matching placebo

    BTA-C585 Matching placebo capsules; single doses

    Drug: BTA-C585 matching placebo
    Single ascending doses to match 50 to 800 mg BTA-C585 capsules
    Other Names:
  • BTA585

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of adverse events [Day 0 to Day 11]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biota Investigational Site San Antonio Texas United States 78209

    Sponsors and Collaborators

    • Biota Pharmaceuticals, Inc.

    Investigators

    • Study Director: Anna Novotney-Barry, Biota Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biota Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02558413
    Other Study ID Numbers:
    • BTA585-001
    First Posted:
    Sep 24, 2015
    Last Update Posted:
    May 30, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by Biota Pharmaceuticals, Inc.
    Viral Diseases
    Antiviral
    Paramyxoviridae Infections
    RSV
    Respiratory Syncytial Virus
    Aviragen Therapeutics, Inc.
    Aviragen Therapeutics
    Aviragen

    Study Results

    No Results Posted as of May 30, 2018