Comparative Pharmacokinetic Study of Dr. Reddy’s Vedolizumab Administered by the Intravenous Route to Normal Healthy Male Volunteers

Phase 1

Registration Number: CTRI/2024/05/067203

Lead Sponsor: Dr. Reddys Laboratories Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Healthy male volunteers, 18 to 50 years of age (both age inclusive), at the time of signing informed consent.

2. In general, good health as determined by a qualified physician based on a comprehensive medical history (including exclusion of progressive multifocal leukoencephalopathy [PML] by specific questioning on symptoms [Appendix III]), vital signs, physical examination, clinical laboratory tests and 12-lead ECG before randomization.

3. Body mass index between 18.5-30.0 kg/m2 (both inclusive) and body weight of 50.0 – 90.0 kg (both inclusive).

4. Screening parameters (vital signs, physical examination, clinical laboratory tests, 12-lead ECG) within the normal range or if outside the normal range then assessed as clinically non-significant by the Investigator (unless the value constitutes an explicit exclusion criterion).

5. Subjects must be willing to avoid sperm donation; and subjects or their female partner (if they are women of childbearing potential [WOCBP]) must be willing to use at least 1 highly effective method of contraception (as per Clinical Trials Facilitation and coordination Group (CTFG) guidelines (adopted and implemented on 21/09/2020))

6. Capable and amenable to providing written informed consent to the study requirements.

7. Willing to stay on study restrictions and contraception for 28 weeks and abide by the study processes till the end of the study (including follow-up period if applicable).

Exclusion Criteria

1. Positive test result or 3 successive indeterminate test results for Quantiferon TB Gold test or positive test result for syphilis, hepatitis B, hepatitis C, or HIV 1/ 2 Virus at screening.

2. Live organism vaccination within 3m prior to randomization or any planned vaccination with live vaccines during the entire study. Non-live vaccines within 6 weeks prior to randomization or any planned vaccination with non-live vaccines during the entire study.

3. Any prior exposure to vedolizumab or to any other agent directly acting on integrin signalling including investigational products.

4. Subject with 1 or more positive responses for the PML symptoms mentioned in the PML Questionnaire at screening or randomization.

5. History of Immunodeficiency or other clinically significant immunological disorders, or auto-immune disorders.

6. Subject with ongoing or frequent/ recurring infection defined as more than 3 infection events per year requiring treatment or prior herpes zoster infection not fully healed including the post-herpetic neuralgia period if occurring within 1 year prior to randomization.

7. Clostridioides difficile infection within 3m, diarrhea lasting for more than 24h within 2m or any other intestinal infection within 1m prior to randomization.

8. History of allergic reaction or any adverse reaction following usage of Sodium Chloride Infusion.

9. History and or current presence of clinically significant in the opinion of the Investigator atopic allergy (e.g., asthma including childhood asthma, urticaria, angioedema, eczematous dermatitis), allergic reactions.

10. Allergy or hypersensitivity to any recombinant human or humanized antibodies, other therapeutic proteins or any excipients of at least one of the tested vedolizumab products or contraindication to the administration of IV fluid including 0.9% sodium chloride.

11. Blood donation, haemorrhage requiring treatment or transfusion, participation in any trial requiring blood sampling in the past 3m, plasma donation within the last 2 weeks or longer duration as per national regulation.

12. Screening or baseline blood pressure higher than 140mm Hg systolic or higher than 90 mm Hg diastolic BP, or volunteers currently on anti-hypertensive drugs.

Note: Up to 2 repeats in different days (on the same day are also allowed if white coat hypertension is suspected) are allowed and, in this case, the mean of the measurements will be used to decide on eligibility. Blood pressure is to be measured on the same arm in the sitting position after 5minutes rest.

13. History of (in the opinion of the investigator) difficulty in obtaining peripheral IV access, history of orthostatic or postural hypotension, fainting spells, or blackouts, history of difficulties with blood sampling - situations that potentially may interfere with the study objectives, as per the opinion of the Investigator.

14. QTc longer than 450 milliseconds or other clinically relevant ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf-Parkinson-White syndrome, presence of a cardiac pacemaker or any other electrocardiographic abnormality considered clinically relevant by the Investigator.

15. History or presence of any clinically relevant nervous system disease including, but not restricted to any stroke/ transient ischaemic attack or seizures other than febrile seizures before the age of 5 years

16. H