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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR2500095973 | Registry Identifier | Chinese Clinical Trial Registry |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHS-1420 | Experimental |
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| HUMIRA® | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHS-1420 | Biological | Dose of 40 mg will be subcutaneously administered to participants in |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t) | 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 |
| Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng | Zhengzhou | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | CHS-1420 | CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1 |
| FG001 | HUMIRA® | Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2025 | Dec 18, 2025 |
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| HUMIRA® |
| Biological |
Dose of 40 mg will be subcutaneously administered to participants in |
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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 Time to Maximum Serum Concentration(Tmax) | 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 Elimination Half-life (t1/2) | 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 |
| Elimination Rate Constant (Kel) | 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 |
| Volumeof Distribution (Vd/F) | 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 |
| Clearance(CL/F) | 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 |
| Immunogenicity Estimands | Presence of anti-adalimumab antibodies | Day1 to Day 65 |
| Safety Estimands | Frequency of Adverse Events | Day1 to Day 65 |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | CHS-1420 | CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1 |
| BG001 | HUMIRA® | Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | all randomized participants | Count of Participants | Participants |
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| Race (NIH/OMB) | all randomized participants | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Oct 2025 | Mean | Standard Deviation | h*ng/mL | 0 to 1536 hours post-dose |
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| Primary | 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 | Posted | Oct 2025 | Mean | Standard Deviation | ng/mL | 0 to 1536 hours post-dose |
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| Secondary | Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t) | 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 | Posted | Mean | Standard Deviation | h*ng/mL | 0 to 1536 hours post-dose |
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| Secondary | Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days) | 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 | Posted | Mean | Standard Deviation | h*ng/mL | 0 to 1536 hours post-dose |
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| Secondary | The Time to Maximum Serum Concentration(Tmax) | 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 | Posted | Median | Full Range | h | 0 to 1536 hours post-dose |
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| Secondary | The Elimination Half-life (t1/2) | 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 | Posted | Mean | Standard Deviation | h | 0 to 1536 hours post-dose |
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| Secondary | Elimination Rate Constant (Kel) | 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 | Posted | Mean | Standard Deviation | 1/h | 0 to 1536 hours post-dose |
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| Secondary | Volumeof Distribution (Vd/F) | 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 | Posted | Mean | Standard Deviation | mL | 0 to 1536 hours post-dose |
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| Secondary | Clearance(CL/F) | 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 | Posted | Mean | Standard Deviation | mL/h | 0 to 1536 hours post-dose |
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| Secondary | Immunogenicity Estimands | Presence of anti-adalimumab antibodies | Posted | Count of Participants | Participants | Day1 to Day 65 |
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| Secondary | Safety Estimands | Frequency of Adverse Events | Posted | Count of Participants | Participants | Day1 to Day 65 |
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from enrollment until end of follow-up, up to 65 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHS-1420 | CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1 | 0 | 119 | 0 | 119 | 59 | 119 |
| EG001 | HUMIRA® | Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1. | 0 | 119 | 0 | 119 | 69 | 119 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood triglycerides increased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Lymphocyte count increased | Investigations | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| White blood cells urine positive | Investigations | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| Blood uric acid increased | Investigations | Systematic Assessment |
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| Total cholesterol/HDL ratio decreased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Electrocardiogram ST-T change | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
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| Neutrophil count increased | Investigations | Systematic Assessment |
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| Platelet count increased | Investigations | Systematic Assessment |
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| Basophil count increased | Investigations | Systematic Assessment |
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| Electrocardiogram PR shortened | Investigations | Systematic Assessment |
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| Electrocardiogram Q wave abnormal | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Urinary occult blood | Investigations | Systematic Assessment |
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| Blood fibrinogen increased | Investigations | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Glycosuria | Renal and urinary disorders | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Bundle branch block right | Cardiac disorders | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | Systematic Assessment |
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| Injection site erythema | General disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Hopeshine-Minsheng Hospital of Xinzheng | (+86) 138-4905-6696 | chenjinxi6688@126.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2025 | Dec 18, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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