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

NCT02558413 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-05-30

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Healthy Volunteers

Interventions

DRUG

BTA-C585 oral capsules

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

DRUG

BTA-C585 matching placebo

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

Sponsors & Collaborators

  • Biota Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Anna Novotney-Barry · Biota Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02558413 on ClinicalTrials.gov