MedTrace Logo

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

NCT02668367 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-05-30

No results posted yet for this study

Summary

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

Conditions

  • Pharmacokinetics
  • Healthy Volunteers

Interventions

DRUG

BTA-C585 oral capsules

BTA-C585; Multiple ascending doses from 100 mg to 600 mg

DRUG

BTA-C585 matching placebo

Multiple ascending doses to match 100 mg to 600 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
2015-11-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

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 NCT02668367 on ClinicalTrials.gov