study ofZYBK2 to evaluate the safety, tolerability, pharmacokinetics andpharmacodynamics in patients with Rheumatoid arthritis.

Phase 1

• Conditions: Health Condition 1: M069- Rheumatoid arthritis, unspecified

• Registration Number: CTRI/2021/09/036874
• Lead Sponsor: Zydus Research Centre Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 <=450 ms]

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

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 < 100

mmHg and/or diastolic blood pressure > 90 mmHg or < 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified