Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

NCT03357939 | Completed Phase 1 DMC

• 1 other identifier: HLX03-HV01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HLX03; adalimumab; pharmacokinetics; biosimilar

Outcome Measures

Primary Outcomes (2)

• Maximum Concentration（Cmax） of Adalimumab After Single SC Injection of HLX03/Humira

  71 days post-dose

• Area Under the Plasma Concentration-time Curve From Zero (0) Hours to the last quantifiable concentration

  71 days post-dose

Secondary Outcomes (3)

• Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity

  71 days post-dose

• Time to Maximum Concentration（Tmax） of Adalimumab After Single SC Injection

  71 days post-dose

• Half-life time of adalimumab after single SC injection of HXL03/Humira

  71 days

Study Arms (2)

HLX03

EXPERIMENTAL

There are about 68 subjects in this group will receive a single dose of 40 mg of HLX03 in 0.8 mL in subcutaneous injection.

Drug: HLX03

Humira

ACTIVE COMPARATOR

There are about 68 subjects in this group will receive a single dose of 40 mg of Humira in a pre-filled syringe in subcutaneous injection.

Drug: adalimumab

Interventions

HLX03 DRUG

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

Also known as: adalimumab biosimilar

HLX03

adalimumab DRUG

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

Also known as: Humira

Humira

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese males (age: 18\~45 yrs) with contraception during and 3 months post-dose. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
• BMI between 19.0 and 28.0 kg/m² and body weight between 55 kg and 80 kg.

You may not qualify if:

• suffering from active or latent tuberculosis or history of tuberculosis;
• have heart disease or a history of heart disease;
• suffer from mental illness or psychiatric history;
• suffering from malignant tumors and their history;
• suffering from herpes zoster and its history;
• suffering from epilepsy and history of epilepsy;
• be allergic to the drugs or its components with high sensitivity or allergic reaction, detection of ADA (+);
• patients who lost blood or donated more than 200 mL within the first 2 months before the screening;
• major surgery performed within 30 days prior to signing ICF;
• live vaccine inoculation or vaccination within 12 weeks of screening, or possible administration of vaccine during screening and study visits;
• previous application of adalimumab or its biosimilars, or anti-TNF alpha drugs;
• participating in other clinical trials within the first 3 months of the trial;
• abnormal immune function within 4 weeks before screening;
• the presence of invasive systemic fungal infection or other opportunistic infections within 2 months prior to screening;
• systemic or local infection, such as the risk of sepsis and / or known active inflammation within 2 months before screening;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

the 1st affiliated hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• Zhang H, Wu M, Sun J, Zhu X, Li C, Ding Y, Zhang X, Chai K, Li X. Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study. Pharmacol Res Perspect. 2021 Apr;9(2):e00733. doi: 10.1002/prp2.733.

  PMID: 33682358 RESULT

Related Links

• FRI0086 CHINA-MANUFACTURED ADALIMUMAB BIOSIMILAR, HLX03, DEMONSTRATED PHARMACOKINETIC EQUIVALENCE AND COMPARABLE SAFETY TO REFERENCE ADALIMUMAB，EULAR 2019 (Poster); Annals of the Rheumatic Diseases

MeSH Terms

Conditions

Immune System Diseases

Interventions

adalimumab biosimilar HS016; Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yanhua Ding, MD

  The 1st affiliated hospital, Jilin University, PRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: November 30, 2017
• Study Start: January 12, 2017
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

CN (1)