Trial Outcomes & Findings for 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 (NCT NCT07147257)
NCT ID: NCT07147257
Last Updated: 2026-01-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
238 participants
Primary outcome timeframe
0 to 1536 hours post-dose
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
CHS-1420
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
119
|
|
Overall Study
COMPLETED
|
118
|
116
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
CHS-1420
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Drug administration failure
|
0
|
1
|
Baseline Characteristics
all randomized participants
Baseline characteristics by cohort
| Measure |
CHS-1420
n=119 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=119 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=158 Participants
|
119 Participants
n=157 Participants
|
238 Participants
n=315 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=158 Participants • all randomized participants
|
44 Participants
n=157 Participants • all randomized participants
|
88 Participants
n=315 Participants • all randomized participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=158 Participants • all randomized participants
|
75 Participants
n=157 Participants • all randomized participants
|
150 Participants
n=315 Participants • all randomized participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants • all randomized participants
|
0 Participants
n=157 Participants • all randomized participants
|
0 Participants
n=315 Participants • all randomized participants
|
|
Race (NIH/OMB)
Asian
|
119 Participants
n=158 Participants • all randomized participants
|
119 Participants
n=157 Participants • all randomized participants
|
238 Participants
n=315 Participants • all randomized participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants • all randomized participants
|
0 Participants
n=157 Participants • all randomized participants
|
0 Participants
n=315 Participants • all randomized participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=158 Participants • all randomized participants
|
0 Participants
n=157 Participants • all randomized participants
|
0 Participants
n=315 Participants • all randomized participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=158 Participants • all randomized participants
|
0 Participants
n=157 Participants • all randomized participants
|
0 Participants
n=315 Participants • all randomized participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants • all randomized participants
|
0 Participants
n=157 Participants • all randomized participants
|
0 Participants
n=315 Participants • all randomized participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants • all randomized participants
|
0 Participants
n=157 Participants • all randomized participants
|
0 Participants
n=315 Participants • all randomized participants
|
|
BMI
|
23.33 kg/m^2
STANDARD_DEVIATION 1.437 • n=158 Participants
|
23.25 kg/m^2
STANDARD_DEVIATION 1.689 • n=157 Participants
|
23.29 kg/m^2
STANDARD_DEVIATION 1.565 • n=315 Participants
|
PRIMARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=117 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=116 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞)
|
2321566.8 h*ng/mL
Standard Deviation 995890.41
|
2358855.5 h*ng/mL
Standard Deviation 1038026.70
|
PRIMARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=119 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=118 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
The Maximum Serum Drug Concentration (Cmax)
|
3602.38 ng/mL
Standard Deviation 1145.963
|
3620.75 ng/mL
Standard Deviation 1489.729
|
SECONDARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=118 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=117 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t)
|
2153350.8 h*ng/mL
Standard Deviation 808597.63
|
2191368.0 h*ng/mL
Standard Deviation 884277.79
|
SECONDARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=118 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=117 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days)
|
2154968.6 h*ng/mL
Standard Deviation 807292.73
|
2192846.0 h*ng/mL
Standard Deviation 883361.98
|
SECONDARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=119 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=118 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
The Time to Maximum Serum Concentration(Tmax)
|
168.000 h
Interval 36.0 to 528.0
|
156.000 h
Interval 12.0 to 360.02
|
SECONDARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=117 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=116 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
The Elimination Half-life (t1/2)
|
240.698 h
Standard Deviation 219.3439
|
238.869 h
Standard Deviation 186.2289
|
SECONDARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=117 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=116 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Elimination Rate Constant (Kel)
|
0.0053 1/h
Standard Deviation 0.0034
|
0.0050 1/h
Standard Deviation 0.0034
|
SECONDARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=117 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=116 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Volumeof Distribution (Vd/F)
|
5489.1 mL
Standard Deviation 3152.11
|
5687.4 mL
Standard Deviation 3240.04
|
SECONDARY outcome
Timeframe: 0 to 1536 hours post-dosepre-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
Outcome measures
| Measure |
CHS-1420
n=117 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=116 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Clearance(CL/F)
|
20.6798 mL/h
Standard Deviation 8.8808
|
20.9731 mL/h
Standard Deviation 10.7637
|
SECONDARY outcome
Timeframe: Day1 to Day 65Presence of anti-adalimumab antibodies
Outcome measures
| Measure |
CHS-1420
n=119 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=118 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Immunogenicity Estimands
ADA positive participants at 0h
|
1 Participants
|
4 Participants
|
|
Immunogenicity Estimands
baseline negative ADA participants with at least one post dose positive ADA result
|
109 Participants
|
100 Participants
|
|
Immunogenicity Estimands
No Anit-Drug Antibody Confirmed Positive Results
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day1 to Day 65Frequency of Adverse Events
Outcome measures
| Measure |
CHS-1420
n=119 Participants
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=119 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Safety Estimands
|
59 Participants
|
69 Participants
|
Adverse Events
CHS-1420
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
HUMIRA®
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CHS-1420
n=119 participants at risk
CHS-1420(adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1
|
HUMIRA®
n=119 participants at risk
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on day 1.
|
|---|---|---|
|
Investigations
Low density lipoprotein increased
|
5.0%
6/119 • from enrollment until end of follow-up, up to 65 days
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
4/119 • from enrollment until end of follow-up, up to 65 days
|
3.4%
4/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
White blood cells urine positive
|
2.5%
3/119 • from enrollment until end of follow-up, up to 65 days
|
4.2%
5/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
White blood cell count decreased
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
4.2%
5/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Blood uric acid increased
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
2.5%
3/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Total cholesterol/HDL ratio decreased
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
2.5%
3/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Electrocardiogram ST-T change
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Blood creatinine increased
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Neutrophil count increased
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Platelet count increased
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Basophil count increased
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Electrocardiogram PR shortened
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Electrocardiogram Q wave abnormal
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Platelet count decreased
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Urinary occult blood
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.5%
3/119 • from enrollment until end of follow-up, up to 65 days
|
3.4%
4/119 • from enrollment until end of follow-up, up to 65 days
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
3.4%
4/119 • from enrollment until end of follow-up, up to 65 days
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
|
Renal and urinary disorders
Glycosuria
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
2.5%
3/119 • from enrollment until end of follow-up, up to 65 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
Cardiac disorders
Bundle branch block right
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
|
General disorders
Injection site erythema
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
1.7%
2/119 • from enrollment until end of follow-up, up to 65 days
|
|
Injury, poisoning and procedural complications
Injury
|
0.84%
1/119 • from enrollment until end of follow-up, up to 65 days
|
0.00%
0/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Blood triglycerides increased
|
19.3%
23/119 • from enrollment until end of follow-up, up to 65 days
|
26.1%
31/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Neutrophil count decreased
|
7.6%
9/119 • from enrollment until end of follow-up, up to 65 days
|
8.4%
10/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Alanine aminotransferase increased
|
7.6%
9/119 • from enrollment until end of follow-up, up to 65 days
|
6.7%
8/119 • from enrollment until end of follow-up, up to 65 days
|
|
Investigations
Lymphocyte count increased
|
2.5%
3/119 • from enrollment until end of follow-up, up to 65 days
|
5.9%
7/119 • from enrollment until end of follow-up, up to 65 days
|
Additional Information
Principal Investigator
Hopeshine-Minsheng Hospital of Xinzheng
Phone: (+86) 138-4905-6696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place