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A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects

NCT02460393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-12-27

No results posted yet for this study

Summary

This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.

Conditions

Interventions

DRUG

Humanized TNFα monoclonal antibody

Subcutaneous injection of different doses for healthy people Subcutaneous injection of different doses in healthy people

OTHER

placebo

Subcutaneous injection of different doses for healthy people

Sponsors & Collaborators

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • China

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 NCT02460393 on ClinicalTrials.gov