A clinical study of DRL adalimumab with Innovator product in Healthy male volunteers

Phase-I, Blinded, Randomized, Parallel-group, Single dose, Comparative Pharmacokinetic Study of DRL_Adalimumab (DRL_AU) and Reference Adalimumab Administered by the Subcutaneous Route to Normal Healthy Male Subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015145

Enrollment

374

Registered

2018-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: DRL_AU: As per the randomization schedule, subjects will be administered a single dose of either test product (T) or reference medicinal product (R1) or reference medicinal product (R2)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male subjects, 18 to 50 years of age 2. BMI between 18.5 - 30.0 kg/m2 and body weight of 50 â?? 80 kg 3. Have all screening results within acceptable range 4. Non-smoker, non-alcoholic and should not be consuming tobacco 5. Capable, and amenable to providing written informed consent to the study requirements.

Exclusion criteria

Exclusion criteria: 1. Positive result for T.B., syphilis, hepatitis B & C, or HIV 2. Live virus vaccination within 3 months prior to screening 3. Any prior exposure to adalimumab or to any other TNF 4. History of immunodeficiency or other clinically significant immunological disorders, or auto-immune disorders. 5. Any history of hypersensitivity or allergic reactions. 6. QTc (Friedericia correction) longer than 450 milliseconds. 7. Any nervous system disease and systemic disease considered as significant 8. Any active infection or non-healed wound ongoing at the time of screening or dosing. 9. Any disorder that may interfere with the safety of the subject, the study evaluations or the subject compliance to the study procedures and limitations. 10. History of any cancer, including carcinoma in situ, lymphoma or leukemia.

Design outcomes

Primary

Measure	Time frame
To demonstrate pharmacokinetic similarity of DRL_AU versus RMPTimepoint: One pre-dose (0.00) blood sample of 3.5 mL will be collected within a period of 2 hours before the drug administration. The post-dose blood samples of 3.5 mL each will be collected at 1.00, 4.00, 8.00, 12.00, 24, 48, 72, 96, 120 (day 6), 144 (day 7), 168 (day 8), 192 (day 9), 240 hour (day 11) and on days 14 (312 hour), 16 (360 hour), 22 (504 hour), 29 (672 hour), 36 (840 hour), 43 (1008 hour),50 (1176 hour), 57 (1344 hour), 64 (1512 hour) and 71 (1680 hour) (end of study).	—

Measure

Time frame

To demonstrate pharmacokinetic similarity of DRL_AU versus RMPTimepoint: One pre-dose (0.00) blood sample of 3.5 mL will be collected within a period of 2 hours before the drug administration. The post-dose blood samples of 3.5 mL each will be collected at 1.00, 4.00, 8.00, 12.00, 24, 48, 72, 96, 120 (day 6), 144 (day 7), 168 (day 8), 192 (day 9), 240 hour (day 11) and on days 14 (312 hour), 16 (360 hour), 22 (504 hour), 29 (672 hour), 36 (840 hour), 43 (1008 hour),50 (1176 hour), 57 (1344 hour), 64 (1512 hour) and 71 (1680 hour) (end of study).

—

Secondary

Measure	Time frame
To assess the safety and tolerability and immunogenicityTimepoint: day 14, 29 and 71	—

Countries

India

Contacts

Public ContactP Krishnanand

Dr. Reddyâ??s Laboratories Ltd

sonicabatra@drreddys.com914044644000

Outcome results