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

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Biological: CHS-1420; Biological: HUMIRA®

Study type: Interventional

Funder types: Industry

Identifiers

NCT07147257

CHS-1420-10

ChiCTR2500095973 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 238 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Able to provide signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs)
2. Able to complete the trial in compliance with the protocol
3. 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
4. Males and females between 18 and 55 years old, inclusive
5. At least 50 kg for participants, with a Body Mass Index(BMI)=Weight/ Height2 (kg/m2) between 19.0-26.0 kg/m2, inclusive
6. No history of chro nic or serious cardiac, hepatic, renal, digestive tract,nervous system, hematologic, respiratory, dermatological, mental and metabolic disorders, etc.

Exclusion criteria

1. With ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial
2. Allergic constitution, or allergic to the drug components and its analogues; history of allergic reaction to a biological medication
3. 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)
4. 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
5. 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
6. Any history of organ transplantation
7. Medical history of tuberculosis (or suspected tuberculosis), or with a positive tuberculosis test result
8. 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
9. Medical history of immune system disorders (e.g. systemic lupus erythematosus, multiple sclerosis, etc.), or positive results of antinuclear antibody tests
10. 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
11. History of seizure attack
12. Medication history of TNF-α blockers e.g. Adalimumab or its analogues
13. Any medication of monoclonal antibodies within the past year before investigational products dosing
14. Any usage history of prescription medicines or OTCs (especially antibiotics), or Chinese herbal medicine or health supplementary within 30 days before investigational products dosing
15. Any vaccination within 3 months before investigational products dosing, or any plan for vaccination within 3 months after investigational products administration
16. Consumption of any special diets or food items (such as grapefruit), or strenuous exercise engagement, or other factors in the opinion of investigators affecting drug absorption, distribution, metabolism and excretion within 7 days before investigational products dosing
17. Participation in other drug clinical trials within 3 months before investigational products dosing
18. Any clinically significant abnormality findings, as judged by a clinical physican, such as physical examination, vital signs, electrocardiogram and laboratory tests, as well as Chest X-ray
19. Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis
20. Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before investigational products dosing
21. Consumption of any products containing alcohol within 48 h before investigational products dosing, or a positive result of the alcohol breath test
22. A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial
23. A positive result of the pregnancy test, or in lactation during screening or the test period for female participants
24. Not tolerable on venipuncture, or a history of fainting on acupuncture and/or blood
25. Special requirements and unable to follow the unified diet
26. Unable to participate in this trial for participants' own reasons
27. Other conditions in which participants are not suitable for the trial determined by investigators

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 2 patient groups

CHS-1420

Experimental group

Treatment:

Biological: CHS-1420

HUMIRA®

Active Comparator group

Treatment:

Biological: HUMIRA®