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A Phase I Study of SB26 in Healthy Volunteers

NCT03630627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-04-24

No results posted yet for this study

Summary

This study is a Phase I, randomized double-blind, placebo-controlled (within a dose group), single and multiple rising dose study of the intravenous administration of SB26 in healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

SB26

SB26 administered intravenously

DRUG

Placebo

Placebo administered intravenously

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • David Han, M.D. · California Clinical Trials Medical Group, a division of PAREXEL International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2020-04-16
Completion
2020-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03630627 on ClinicalTrials.gov