Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safet… (NCT06929039) | Clinical Trial Compass
CompletedPhase 1
Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects
Canada300 participantsStarted 2024-07-04
Plain-language summary
The goal of this clinical trial is to learn if Test Product KSHB002 shows equivalence in terms of PK , safety and immunogenicity as compared to reference product ORENCIA used to treat Rheumatoid arthritis .
Participants will:
Take drug Test or a reference subcutaneously as a single dose and these participants will be healthy volunteers
Primary Endpoint: The following pharmacokinetic parameters will be determined as: Cmax and AUCi, of KSHB002 (Abatacept), US-licensed ORENCIA and EU-authorized ORENCIA.
Secondary Endpoint : Safety will be evaluated from occurrence of adverse events post dose. The number, severity and relation to treatment will be collected by the reporting of the adverse events (AE) and monitoring of clinically relevant changes e.g., vital signs, physical examination and lab values in blood and urine.
* Immunogenicity will be evaluated from the number/percentage of subjects positive for ADA (Anti-Drug Antibody) and Neutralizing Anti-drug antibody
* Secondary pharmacokinetic endpoints will be evaluated as AUCt, Tmax, Kel and tHalf.
Who can participate
Age range
18 Years – 65 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:
* Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test at screening. They must be using an acceptable form of contraception.
B. For female of childbearing potential, acceptable forms of contraception include the following:
i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months. 3) BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.95 rounds up to 19.0).
4\) Body weight: 50.0 kg to 100.0 kg both inclusive. 5) Able to communicate effectivel…
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.
1This trial was done in healthy volunteers, not people with rheumatoid arthritis — so what does that mean for how relevant the safety and pharmacokinetic data would be for someone like me who actually has RA?
2Since this was a Phase 1 single-dose study focused on how the drug moves through the body rather than whether it actually treats RA, does that mean there's not yet solid evidence about whether this drug works for rheumatoid arthritis symptoms?
3The trial compared three arms in a single-dose design, which sounds like it may be testing a biosimilar or comparing different formulations — can you tell me what drugs were being compared and how that affects my treatment options?
4Given that this study is already completed, would you be able to share or access the results, and how would those findings factor into any treatment decision we might make together?
5Are there other ongoing or completed trials for this drug that have actually tested it in RA patients over a longer period, so we can better understand the real-world safety and effectiveness picture before considering it as an option for me?
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.