NCT03357939

Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, doubl-blinded, parellel-controlled phase 1 PK, safety, tolerability and immunogenicitiy study to compare HLX03, designed as an Adalimumab biosimilar, with China sourced Humira in Chinese health volunteers. All enrolled subjects will receive a single dose of HLX03 (40 mg）or Humira(adalimumab, 40 mg) in subcutaneous injectioin after randomization. The purpose of this study to prove the similarity in PK, Safety, tolerability and immunogenicity beween HLX03（adalimumab biosimilar） and China sourced Humira and provide evidence for Phase III comparison study. The blood will be collected before drug administration, and at 1 hr、4 hr、8 hr、24 hr (1d)、48 hr (2d)、72 hr (3d)、96 hr (4d)、、144 hr (6d)、192 hr (8d)、240 hr (10d)、 336 hr (14d)、504 hr (21d)、672 hr (28d)、840 hr (35d)、1008 hr (42d)、1176 hr (49d)、1344 hr (56d)、1680 hr (70d) after drug injection for PK, ADA, etc analysis. All subjects also will be followed up at 0, 1,2,3,4,6,8,10,14,21,28,35, 42, 49, 56, and 70 days after drug administration for AE and other specified outcomes. The main endpoint is AUC from time zero to ∞. The second endpoints include Cmax, Tmax, T1/2, CL, Vd and AUC（0-last）. This is single center study in China.

Conditions

• Immune System Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-12
• Primary completion: 2018-09-15
• Completion: 2018-09-15
• First posted: 2017-11-30
• Last updated: 2022-05-09

Locations

1 site across 1 country: China