Trial results for a Phase 1 study comparing CHS-1420, an adalimumab biosimilar, to HUMIRA® (Adalimumab) were posted on ClinicalTrials.gov on 2026-01-09. The study, conducted in healthy Chinese adult participants, aimed to assess pharmacokinetic similarity between the two formulations. Key pharmacokinetic parameters, including AUC and Cmax, showed comparable profiles between CHS-1420 and HUMIRA®.
Background
Adalimumab is a well-established monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. It is approved for various autoimmune and inflammatory conditions. CHS-1420 is being developed as a biosimilar to reference Adalimumab (HUMIRA®).
Trial design
The study (NCT07147257) was a Phase 1, single-center, randomized, single-blind, single-dose, parallel-group trial. It enrolled 238 healthy Chinese adult participants under fasting conditions. The trial's objective was to assess the pharmacokinetic similarity between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL.
Key results
The trial evaluated several pharmacokinetic parameters to assess similarity between CHS-1420 and HUMIRA®.
- For Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞):
- CHS-1420: Mean of 2321566.8 h*ng/mL (Standard Deviation: 995890.41)
- HUMIRA®: Mean of 2358855.5 h*ng/mL (Standard Deviation: 1038026.70)
- For The Maximum Serum Drug Concentration (Cmax):
- CHS-1420: Mean of 3602.38 ng/mL (Standard Deviation: 1145.963)
- HUMIRA®: Mean of 3620.75 ng/mL (Standard Deviation: 1489.729)
- For Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t):
- CHS-1420: Mean of 2153350.8 h*ng/mL (Standard Deviation: 808597.63)
- HUMIRA®: Mean of 2191368.0 h*ng/mL (Standard Deviation: 884277.79)
- For Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose (AUC0-65days):
- CHS-1420: Mean of 2154968.6 h*ng/mL (Standard Deviation: 807292.73)
- HUMIRA®: Mean of 2192846.0 h*ng/mL (Standard Deviation: 883361.98)
- For The Time to Maximum Serum Concentration (Tmax):
- CHS-1420: Median of 168.000 h
- HUMIRA®: Median of 156.000 h
- For The Elimination Half-life (t1/2):
- CHS-1420: Mean of 240.698 h (Standard Deviation: 219.3439)
- HUMIRA®: Mean of 238.869 h (Standard Deviation: 186.2289)
What this means
The pharmacokinetic data from this Phase 1 trial indicate that CHS-1420 demonstrated comparable pharmacokinetic profiles to HUMIRA® in healthy Chinese adult participants. The similar mean values and overlapping standard deviations for key parameters are consistent with establishing pharmacokinetic similarity, a critical step for biosimilar development.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT07147257, titled '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,' were posted on 2026-01-09 on clinicaltrials.gov.