NCT07147257

A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting Conditions

A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants under Fasting Conditions

Conditions

• Healthy Participants

Interventions

Type	Name	Description
BIOLOGICAL	CHS-1420	Dose of 40 mg will be subcutaneously administered to participants in
BIOLOGICAL	HUMIRA®	Dose of 40 mg will be subcutaneously administered to participants in

Timeline

• Start date: 2025-02-12
• Primary completion: 2025-05-06
• Completion: 2025-05-29
• First posted: 2025-08-29
• Last updated: 2026-01-28
• Results posted: 2026-01-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study