MedTrace Logo

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

NCT07147257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2026-01-28

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-12
Primary Completion
2025-05-06
Completion
2025-05-29
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT07147257 on ClinicalTrials.gov