Overview

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

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Treatments:
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunoglobulins