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 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CHS-1420-10ChiCTR2500095973
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adalimumab; Pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞)

  pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose

  0 to 1536 hours post-dose

• The Maximum Serum Drug Concentration (Cmax)

  pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose

  0 to 1536 hours post-dose

Secondary Outcomes (9)

• Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t)

  0 to 1536 hours post-dose

• Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days)

  0 to 1536 hours post-dose

• The Time to Maximum Serum Concentration(Tmax)

  0 to 1536 hours post-dose

• The Elimination Half-life (t1/2)

  0 to 1536 hours post-dose

• Elimination Rate Constant (Kel)

  0 to 1536 hours post-dose

Study Arms (2)

CHS-1420

EXPERIMENTAL

Biological: CHS-1420

HUMIRA®

ACTIVE COMPARATOR

Biological: HUMIRA®

Interventions

CHS-1420 BIOLOGICAL

Dose of 40 mg will be subcutaneously administered to participants in

CHS-1420

HUMIRA® BIOLOGICAL

Dose of 40 mg will be subcutaneously administered to participants in

HUMIRA®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs)
• Able to complete the trial in compliance with the protocol
• Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 6 months after the last scheduled visit
• Males and females between 18 and 55 years old, inclusive
• At least 50 kg for participants, with a Body Mass Index(BMI)=Weight/ Height2 (kg/m2) between 19.0-26.0 kg/m2, inclusive
• No history of chro nic or serious cardiac, hepatic, renal, digestive tract,nervous system, hematologic, respiratory, dermatological, mental and metabolic disorders, etc.

You may not qualify if:

• With ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial
• Allergic constitution, or allergic to the drug components and its analogues; history of allergic reaction to a biological medication
• A history of alcohol abuse (alcohol consumption of more than 14 units per week : 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine)
• Blood donation or massive blood loss (\> 400 mL) within 3 months before investigational products dosing; Or any blood donation plan from screening until 3 months after administration
• History of any major surgery within the past year, or history of any surgery within the past 6 months; or any elective medical procedures, including dental procedures
• Any history of organ transplantation
• Medical history of tuberculosis (or suspected tuberculosis), or with a positive tuberculosis test result
• Medical history of heart failure or other cardiac disorders which may lead to heart failure, e.g. coronary heart disease, hypertension, senile degenerative valvular disease, rheumatic valvular heart disease, dilated cardiomyopathy, acute severe myocarditis
• Medical history of immune system disorders (e.g. systemic lupus erythematosus, multiple sclerosis, etc.), or positive results of antinuclear antibody tests
• Medical history of recurrent or chronic infections (including transverse myelitis, optic neuritis, other demyelinating disorders, etc.), or a history of an opportunistic infection within the past year due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens
• History of seizure attack
• Medication history of TNF-α blockers e.g. Adalimumab or its analogues
• Any medication of monoclonal antibodies within the past year before investigational products dosing
• Any usage history of prescription medicines or OTCs (especially antibiotics), or Chinese herbal medicine or health supplementary within 30 days before investigational products dosing
• Any vaccination within 3 months before investigational products dosing, or any plan for vaccination within 3 months after investigational products administration

Sponsors & Collaborators

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

Study Sites (1)

Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng

Zhengzhou, China

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Principal Investigator
• Organization: Hopeshine-Minsheng Hospital of Xinzheng

chenjinxi6688@126.com

(+86) 138-4905-6696

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 29, 2025
• Study Start: February 12, 2025
• Primary Completion: May 6, 2025
• Study Completion: May 29, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 9, 2026

Record last verified: 2025-08

Locations

CN (1)