Rheumatoid Arthritis (RAPhase 1abataceptNCT06929039
Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects
A Phase 1 study testing Abatacept in people with Rheumatoid Arthritis (RA, run by Kashiv BioSciences, LLC at 1 site in Canada.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2024to 25 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- For female of childbearing potential, acceptable forms of contraception include the following:
- 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.
- Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- 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 effectively with study personnel. 6) Willing to provide written informed consent to participate in the study. 7) Judged by the investigator and/or designee to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any clinical testing (laboratory tests, ECG, etc.) can be repeated at the discretion of the investigator and/or designee and judged to be not clinically significant for study participation. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation
Who cannot join
- History of allergic responses to Abatacept or other related drugs, or any of its formulation ingredients.
- 2) Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- 3) History or presence of chronic obstructive pulmonary disease (COPD). 4) Use of any hormone replacement therapy within 3 months prior to the study medication administration.
- 5) Use of any depot injection or implant of any drug within 3 months prior to the study medication administration.
- 6) Use of CYP enzyme inhibitors or inducers within 30 days prior to the study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
- 7) History or evidence of drug dependence. 8) Reports smoking or using tobacco products or is currently using nicotine products (cigarettes, patches, gums, etc.) 14 days prior to screening.
Show all 19Show fewer
- 9) Reports history of drug or alcohol addiction or abuse within the past 1 year.
- 10) History of difficulty with donating blood or difficulty in accessibility of veins.
- 11) A positive hepatitis screen (hepatitis B surface antigen, hepatitis C antibody).
- 12) A positive test result for HIV antibody. 13) A positive QuantiFERON®-TB Gold Plus (Tuberculosis) test. 14) Volunteers who have received a known investigational drug within seven elimination half-lives of the administered drug prior to the study medication administration.
- 15) Reports a blood donation totaling between 101 mL to 499 mL within 30 days prior to study drug administration or a blood donation of more than 499 mL within 56 days prior study drug administration for male volunteers and 84 days prior to study drug administration for female volunteers. All volunteers will be advised not to donate blood for 30 days after completing the study.
- 16) Intolerance to venipuncture 17) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
- 18) Institutionalized volunteers. 19) Use of any prescribed medications within 14 days prior to the study medication administration.
- 20) Use of any OTC products, vitamin and herbal products, etc., within 14 days prior to the study medication administration.
- 21) Use of grapefruit and grapefruit containing products within 7 days prior to the study medication administration.
- 22) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for 48 hours prior to administration of study drug, recreational drugs within 30 days prior to screening.
- 23) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the study medication administration.
- 24) History of anaphylactic shock. 25) Subjects with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
- 26) Subject has received any live vaccine within one month preceding study drug administration or not able to avoid live vaccines until three months after dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized , Open Label, Three Arm, Parallel Group, Single Dose, Comparative Pharmacokinetic , Safety, and Immunogenicity Study Comparing KSHB002 (Abatacept) 125 mg/ ml Pre-filled Injection With US-Licenced ORENCIA and EU-Approved ORENCIA Administered Through Subcutaneous Route in Healthy Adult Human Volunteers
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:
Read more
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.
Read the detailed description
A randomized, open label three-arm, parallel group, single dose comparative pharmacokinetic, safety and immunogenicity study comparing KSHB002 (Abatacept) Injection, 125 mg/mL with US-licensed ORENCIA and EU-authorized ORENCIA administered through subcutaneous route in healthy adult human subjects.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- Abatacept
- Keywords
- abatacept, kashiv biosciences
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Test Product (A) (Kashiv's Abatacept): KSHB002 (Abatacept) Injection, 125 mg/mL - Manufactured by: Kashiv Bioscience's LLC, USA.
AbataceptDrug
Reference Product (B) (US-licensed ORENCIA): 'ORENCIA' (abatacept) injection 125 mg/mL - Manufactured for: Bristol-Myers Squibb Company Princeton, NJ 08543 USA.
AbataceptDrug
Reference Product (C) (EU-authorized ORENCIA): 'ORENCIA' 125 mg solution for injection (abatacept) - Marketing Authorization Holder: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Test Product- KSHB002 Abatacept 125mg/ml Pre-filled syringe Receives: Drug: Abatacept |
| Reference Product 1 | Active comparator | US-Liceneced Orencia 125mg/ml Pre-filled syringe Receives: Drug: Abatacept |
| Reference product 2 | Active comparator | EU-Approved Orencia 125mg/ml pre-filled injection Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter
Cmax
Measured: from baseline till day 70
Pharmacokinetic parameter
AUCi
Measured: from baseline to day 70
Secondary outcomes (4)
Pharmacokinetic parameter
AUCt
Measured: from baseline to day 70
pharmacokinetic parameter
Tmax
Measured: from baseline to day 70
Pharmacokinetic parameter
T1/2
Measured: Baseline to day 70
Pharmacodynamic
ADA (Anti-Drug Antibody) and Neutralizing Anti-drug antibody
Measured: basleline to day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start4 Jul 2024
- Primary completion16 Oct 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kashiv BioSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pawan Singh, MD DM, Study chair, Kashiv BiosciencesSivakumar Vaidyanathan, M.Pharm, Study director, Kashiv Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929039
- Sponsor's protocol ID
- KSHB002
- Acronym
- abatacept
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized , Open Label, Three Arm, Parallel Group, Single Dose, Comparative Pharmacokinetic , Safety, and Immunogenicity Study Comparing KSHB002 (Abatacept) 125 mg/ ml Pre-filled Injection With US-Licenced ORENCIA and EU-Approved ORENCIA Administered Through Subcutaneous Route in Healthy Adult Human Volunteers
- ClinicalTrials.gov ID
- NCT06929039
- Acronym / sponsor ID
- abatacept / KSHB002
- Conditions
- Rheumatoid Arthritis (RA
- Keywords
- abatacept, kashiv biosciences
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kashiv BioSciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, open label three-arm, parallel group, single dose comparative pharmacokinetic, safety and immunogenicity study comparing KSHB002 (Abatacept) Injection, 125 mg/mL with US-licensed ORENCIA and EU-authorized ORENCIA administered through subcutaneous route in healthy adult human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: AbataceptTest Product- KSHB002 Abatacept 125mg/ml Pre-filled syringe |
| Reference Product 1 | Active comparator | Drug: AbataceptUS-Liceneced Orencia 125mg/ml Pre-filled syringe |
| Reference product 2 | Active comparator | Drug: AbataceptEU-Approved Orencia 125mg/ml pre-filled injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- For female of childbearing potential, acceptable forms of contraception include the following:
- 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.
- Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- 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).
Key exclusion criteria (19 listed)
- History of allergic responses to Abatacept or other related drugs, or any of its formulation ingredients.
- 2) Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- 3) History or presence of chronic obstructive pulmonary disease (COPD). 4) Use of any hormone replacement therapy within 3 months prior to the study medication administration.
- 5) Use of any depot injection or implant of any drug within 3 months prior to the study medication administration.
- 6) Use of CYP enzyme inhibitors or inducers within 30 days prior to the study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
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 |
|---|---|---|
| AbataceptTest Product (A) (Kashiv's Abatacept): KSHB002 (Abatacept) Injection, 125 mg/mL - Manufactured by: Kashiv Bioscience's LLC, USA. | Drug | Test Product |
| AbataceptReference Product (B) (US-licensed ORENCIA): 'ORENCIA' (abatacept) injection 125 mg/mL - Manufactured for: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. | Drug | Reference Product 1 |
| AbataceptReference Product (C) (EU-authorized ORENCIA): 'ORENCIA' 125 mg solution for injection (abatacept) - Marketing Authorization Holder: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland. | Drug | Reference product 2 |
Primary outcome
Pharmacokinetic parameter
Time frame: from baseline till day 70
Cmax
Pharmacokinetic parameter
Time frame: from baseline to day 70
AUCi
4 secondary outcomes
Pharmacokinetic parameter
Time frame: from baseline to day 70
pharmacokinetic parameter
Time frame: from baseline to day 70
Pharmacokinetic parameter
Time frame: Baseline to day 70
Pharmacodynamic
Time frame: basleline to day 70
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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.
Pawan Singh, MD DM study chair
Kashiv Biosciences
Sivakumar Vaidyanathan, M.Pharm study director
Kashiv Biosciences
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 Abatacept in people with Rheumatoid Arthritis (RA, run by Kashiv BioSciences, LLC at 1 site in Canada.
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 19 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 12 Jun 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic parameter (time frame: from baseline till day 70). 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 12 Jun 2026.