Healthy ParticipantsPhase 1NCT07147257
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
A Phase 1 study testing CHS-1420 and HUMIRA® in people with Healthy Participants, run by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- CHS-1420 and HUMIRA®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2025to 29 May 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to provide signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs)
- Able to complete the trial in compliance with the protocol
- 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
- Males and females between 18 and 55 years old, inclusive
- At least 50 kg for participants, with a Body Mass Index(BMI)=Weight/ Height2 (kg/m2) between 19.0-26.0 kg/m2, inclusive
- No history of chro nic or serious cardiac, hepatic, renal, digestive tract,nervous system, hematologic, respiratory, dermatological, mental and metabolic disorders, etc.
Who cannot join
- With ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial
- Allergic constitution, or allergic to the drug components and its analogues; history of allergic reaction to a biological medication
- 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)
- 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
- 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
- Any history of organ transplantation
Show all 27Show fewer
- Medical history of tuberculosis (or suspected tuberculosis), or with a positive tuberculosis test result
- 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
- Medical history of immune system disorders (e.g. systemic lupus erythematosus, multiple sclerosis, etc.), or positive results of antinuclear antibody tests
- 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
- History of seizure attack
- Medication history of TNF-α blockers e.g. Adalimumab or its analogues
- Any medication of monoclonal antibodies within the past year before investigational products dosing
- Any usage history of prescription medicines or OTCs (especially antibiotics), or Chinese herbal medicine or health supplementary within 30 days before investigational products dosing
- Any vaccination within 3 months before investigational products dosing, or any plan for vaccination within 3 months after investigational products administration
- 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
- Participation in other drug clinical trials within 3 months before investigational products dosing
- 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
- Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis
- Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before investigational products dosing
- Consumption of any products containing alcohol within 48 h before investigational products dosing, or a positive result of the alcohol breath test
- 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
- A positive result of the pregnancy test, or in lactation during screening or the test period for female participants
- Not tolerable on venipuncture, or a history of fainting on acupuncture and/or blood
- Special requirements and unable to follow the unified diet
- Unable to participate in this trial for participants' own reasons
- Other conditions in which participants are not suitable for the trial determined by investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng
Zhengzhou
About this study
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
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
- Conditions
- Healthy Participants
- Being tested
- CHS-1420, HUMIRA®
- Keywords
- Adalimumab, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHS-1420Biological
Dose of 40 mg will be subcutaneously administered to participants in
HUMIRA®Biological
Dose of 40 mg will be subcutaneously administered to participants in
| Study group | Role | What they receive |
|---|---|---|
| CHS-1420 | Experimental | Not described Receives: Biological: CHS-1420 |
| HUMIRA® | Active comparator | Not described Receives: Biological: HUMIRA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0 to 1536 hours post-dose
Secondary outcomes (9)
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
Measured: 0 to 1536 hours post-dose
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 to 1536 hours post-dose
Immunogenicity Estimands
Presence of anti-adalimumab antibodies
Measured: Day1 to Day 65
Safety Estimands
Frequency of Adverse Events
Measured: Day1 to Day 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start12 Feb 2025
- Primary completion6 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147257
- Sponsor's protocol ID
- CHS-1420-10
- Other IDs
- ChiCTR2500095973
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07147257
- Acronym / sponsor ID
- CHS-1420-10
- Conditions
- Healthy Participants
- Keywords
- Adalimumab, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHS-1420 | Experimental | Biological: CHS-1420 |
| HUMIRA® | Active comparator | Biological: HUMIRA® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to provide signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs)
- Able to complete the trial in compliance with the protocol
- 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
- Males and females between 18 and 55 years old, inclusive
- At least 50 kg for participants, with a Body Mass Index(BMI)=Weight/ Height2 (kg/m2) between 19.0-26.0 kg/m2, inclusive
Key exclusion criteria (27 listed)
- With ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial
- Allergic constitution, or allergic to the drug components and its analogues; history of allergic reaction to a biological medication
- 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)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHS-1420Dose of 40 mg will be subcutaneously administered to participants in | Biological | CHS-1420 |
| HUMIRA®Dose of 40 mg will be subcutaneously administered to participants in | Biological | HUMIRA® |
Primary outcome
Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞)
Time frame: 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
The Maximum Serum Drug Concentration (Cmax)
Time frame: 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
9 secondary outcomes
Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t)
Time frame: 0 to 1536 hours post-dose
Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days)
Time frame: 0 to 1536 hours post-dose
The Time to Maximum Serum Concentration(Tmax)
Time frame: 0 to 1536 hours post-dose
The Elimination Half-life (t1/2)
Time frame: 0 to 1536 hours post-dose
Elimination Rate Constant (Kel)
Time frame: 0 to 1536 hours post-dose
Volumeof Distribution (Vd/F)
Time frame: 0 to 1536 hours post-dose
Clearance(CL/F)
Time frame: 0 to 1536 hours post-dose
Immunogenicity Estimands
Time frame: Day1 to Day 65
Safety Estimands
Time frame: Day1 to Day 65
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHS-1420 and HUMIRA® in people with Healthy Participants, run by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) (time frame: 0 to 1536 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.