Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: ZYBK2 250 mcg Injection: 1)Route :- Subcutaneous. 2) Frequency :- single dose.
Control Intervention1: Placebo 250 mcg Injection: 1)Route :- Subcutaneous. 2) Frequency :- single dose.
Sponsors
Zydus Research Centre Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and non-lactating non-pregnant female between 18 and 65 years of age (both inclusive) at the time of signing the informed consent form (ICF). 2. Body mass index of 18.5 to 32.0 kg/m2 (Both inclusive) with a body weight >= 45 kg. 3. Normal QTc interval at screening and CheckIn [QTcF 4. Capable of giving signed informed consent which includes compliance with the study procedures, restrictions, and requirements listed in the protocol 5. Diagnosis of rheumatoid arthritis made by a rheumatologist 6. Treatment with a stable oral RA treatment regimen for >= 4 weeks before screening and till study drug administration 7.Male patients must comply with contraception requirements (refer annexure IX) from the time of study drug administration till 90 days after the last dose of study medication. In addition, male patients must not donate sperm for 90 days after the last dose of study medication. 8. Female patients with history of sterility or at least 1 year menopause or use of highly effective contraception (refer annexure IX) during the study and be willing and able to continue contraception for 90 days after their last administration of study treatment.
Exclusion criteria
Exclusion criteria: 1.Use of anti-TNF or other biologics in previous 3 months. 2. Any intra-articular injection therapy (e.g., corticosteroid, hyaluronan) required for treatment of acute RA flare within 4 weeks before randomization 3. Currently receiving or have received treatment with steroids within the last 2 weeks prior to study drug administration. 4. Previous treatment with a B cell-depleting biologic agent or any other immunomodulatory biologic agent within 5 half-lives (experimental or approved) 5. Autoimmune disease other than RA 6. Abnormal findings on ECG considered clinically significant by the investigator. 7. Any surgical procedure, including bone or joint surgery/synovectomy within last 3 months or any planned surgery within the duration of the study or follow-up period 8. Serious infection requiring hospitalization within last 28 days from screening visit till study drug administration 9. Other medications (including vitamins, herbal and dietary supplements) will be considered on a case-by-case basis, and will be allowed if patient is taking these medication at a stable dose from 4 weeks prior to screening till study drug administration and in the opinion of the investigator the medication will interfere with the study procedures or compromise patient safety. 10. Patients who cannot refrain from consuming any of the following fruits or juices (alone or in combination): grapefruit or any citrus fruits from 7 days prior to the first dose of study medication until their discharge from the unit. 11. History of sensitivity to any components of the study medication, or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates their participation 12. History of any significant respiratory, cardiovascular, cerebrovascular, dermatological, gastrointestinal, gynecological, hematological, hepatic, malignancy, metabolic,neurological, psychiatric, renal, venereal or any other major disease which (in the opinion of the investigator) would compromise patient safety or the ability of the patient to complete the study. 13. History or presence of significant alcoholism or drug abuse within the past 1 year OR a positive urine drug screen test or positive alcohol breath test at check-in 14. History or presence of significant smoking or consumption of tobacco/nicotine products 15. Difficulty with donating blood. 16. Patients having systolic blood pressure >140 mmHg or mmHg and/or diastolic blood pressure > 90 mmHg or mmHg despite on stable medication 17. Pulse rate less than 55/minute and more than 100/minute. 18. Volunteers who have donated one unit (350 ml) of blood in the past 3 months. 19. History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II. 20. Female patients who are pregnant, currently breastfeeding, or attempting to conceive. 21. Any disorder that, in the Investigatorâ??s opinion, may interfere with study compliance, such as significant mental, nervous
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety and tolerability of ZYBK2 administered to patients with Rheumatoid arthritisTimepoint: Pre-dose, 15 min; 30 min; 45 min; 1 hour; 2 hour; 4 hour; 6 hour; 8 hour; 12 hour post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetics of ZYBK2 when administered as a single subcutaneous dose to patients with Rheumatoid arthritisTimepoint: Pre-dose, 15 min; 30 min; 45 min; 1 hour; 2 hour; 4 hour; 6 hour; 8 hour; 12 hour post dose | — |
Countries
India
Contacts
Public ContactDr Sandipkumar V Barvaliya
Cadila Healthcare Ltd
Outcome results
None listed