A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adali… (NCT07147257) | Clinical Trial Compass
CompletedPhase 1
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
China238 participantsStarted 2025-02-12
Plain-language 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
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞)
. 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
. 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