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Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects

NCT03097341 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-06-05

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of xisomab 3G3 in healthy adult subjects.

Conditions

Interventions

DRUG

xisomab 3G3- Dose 1

Participants will receive a single intravenous dose of 0.1 mg/kg xisomab 3G3.

DRUG

xisomab 3G3-Dose 2

Participants will receive a single intravenous dose of 0.5 mg/kg xisomab 3G3.

DRUG

xisomab 3G3-Dose 3

Participants will receive a single intravenous dose of 2.0 mg/kg xisomab 3G3.

DRUG

xisomab 3G3- Dose 4

Participants will receive a single intravenous dose of 5.0 mg/kg xisomab 3G3.

OTHER

Placebo

Participants will receive a single intravenous dose of placebo.

Sponsors & Collaborators

  • Aronora, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2018-01-16
Completion
2018-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03097341 on ClinicalTrials.gov