> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-to-assess-the-pharmacokinetic-similarity-between-chs-9f6d0974-f115-419d-ac87-248411c673e9 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) Participants 238 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) Lead sponsor Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) Start date 2025-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Dates **Completion date** 2025-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **First posted** 2025-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Registry last updated** 2026-01-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Primary completion date** 2025-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Start date** 2025-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Size and sites **Actual participants** 238 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Participants** 238 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Lead sponsor** Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Identifiers **Registry ID** NCT07147257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **ClinicalTrials.gov ID** NCT07147257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Outcomes ### Primary outcomes 1. Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) Timeframe: 0 to 1536 hours post-dose 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 2. The Maximum Serum Drug Concentration (Cmax) Timeframe: 0 to 1536 hours post-dose 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 ### Secondary outcomes 1. Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t) Timeframe: 0 to 1536 hours post-dose 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 2. Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days) Timeframe: 0 to 1536 hours post-dose 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 3. The Time to Maximum Serum Concentration(Tmax) Timeframe: 0 to 1536 hours post-dose 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 4. The Elimination Half-life (t1/2) Timeframe: 0 to 1536 hours post-dose 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 5. Elimination Rate Constant (Kel) Timeframe: 0 to 1536 hours post-dose 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 6. Volumeof Distribution (Vd/F) Timeframe: 0 to 1536 hours post-dose 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 7. Clearance(CL/F) Timeframe: 0 to 1536 hours post-dose 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 8. Immunogenicity Estimands Timeframe: Day1 to Day 65 Presence of anti-adalimumab antibodies 9. Safety Estimands Timeframe: Day1 to Day 65 Frequency of Adverse Events Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Sites - Ethics Committee of Hopeshine-Minsheng Hospital of XinzhengZhengzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## References ### Other registry identifiers - ChiCTR2500095973 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147257) ## Related records ### Drugs (1) - [Adalimumab](https://trialight.com/data/asset/adalimumab-77d73b6e-cb34-48b5-9716-a71bee4e5e02.md) ### Lead sponsors (1) - [Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.](https://trialight.com/data/company/nanjing-king-friend-biochemical-pharmaceutical-co-ltd-7aa0a1f6-69b7-4685-830d-90014a91b64c.md) ### Targets (1) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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