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Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

NCT03357939 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-05-09

No results posted yet for this study

Summary

This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.

Conditions

  • Immune System Disorder

Interventions

DRUG

HLX03

A single dose of 40 mg HLX03 in 0.8 mL in subcutaneous injection.

DRUG

adalimumab

A single dose of 40 mg Humira in 0.8 mL in a pre-filled syringe

Sponsors & Collaborators

Principal Investigators

  • Yanhua Ding, MD · The 1st affiliated hospital, Jilin University, PRC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-12
Primary Completion
2018-09-15
Completion
2018-09-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03357939 on ClinicalTrials.gov