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Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers

NCT01660230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-02-05

Study results available
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Summary

The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.

Conditions

  • Healthy

Interventions

BIOLOGICAL

3K3A-APC, diluted in 0.9% sodium chloride in water

DRUG

0.9% NaCl in water

Sponsors & Collaborators

  • ZZ Biotech, LLC

    lead INDUSTRY

Principal Investigators

  • Patrick D Lyden, MD, FAAN · Cedars-Sinai Medical Center

  • Howard Levy, MD, PhD, MMM · ZZ Biotech, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Austria

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 NCT01660230 on ClinicalTrials.gov