A Comparative Evaluation of Pharmacokinetics and Immunogenicity. (NCT06918587) | Clinical Trial Compass
CompletedPhase 1
A Comparative Evaluation of Pharmacokinetics and Immunogenicity.
Jordan180 participantsStarted 2024-09-05
Plain-language summary
The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects.
Subjects safety and immunogenicity will also be evaluated during these study as follows Safety - monitoring the adverse events , vitals signs, ECG, laboratory parameters, and injection site assessment.
Immunogenicity assessment- detection of ADA (Anti-PEG antibody levels ) and Nab (Neutralizing antibodies) will be done pre-dose and post dose on day 15 of each period.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Subjects are physically and mentally healthy adults aged between 18 and 50 years (both inclusive) at screening.
✓. Subject's weight within normal range according to normal values for Body Mass Index (18.5 to 30.0 kg/m2) (both inclusive) with minimum of 50 kg weight at screening.
✓. The findings of the subject are within the range of clinical acceptability in medical history, medication history, clinical examination, and laboratory examinations "other than RBC indices (MCH, MCV and MCHC) and hemoglobin" are within "normal ranges" or abnormalities considered insignificant and justified by the principal/clinical sub- Investigator at screening.
✓. The subject results of all RBC indices (MCH, MCV and MCHC) and hemoglobin are within normal range or ± 5% of medical lab reference range at screening.
✓. The subject's kidney function tests (Serum Creatinine, Potassium, Sodium) are within the medical lab reference range, and kidney function tests (urea, and chloride) are considered clinically acceptable as per the investigator judgment at screening. If creatinine is below the lower normal limit while the other parameters are normal, it will be considered as clinically not significant unless otherwise judged by the investigator.
✓.The subject's Cholesterol level is considered clinically acceptable as per PI / SI judgment at screening.
.The subject is fasting for at least 12 hrs before giving the samples required for clinical laboratory examinations as checked at screening .
✓.Subject having vital signs parameters (blood pressure, body temperature, pulse rate and respiratory rate) are within the following ranges at screening, and on admission day (before admission) of period I: Blood Pressure: Systolic: (90- 140) mmHg, Diastolic: (60-90) mmHg Body Temperature: (36.1 - 37.2) ºC Pulse rate: 60 to 100 beat per minute. Respiratory rate: 12-18 bpm. 10.Subject complies with Injection site evaluation at screening and on admission day (before admission) of period I.
Exclusion criteria
✕. The subject has history of allergy or hypersensitivity to study drug or adhesive material or related class of drugs or to the inactive ingredients (acetate/acetic acid, polysorbate 20, or sorbitol) of the test and reference formulation as checked at screening.
✕. The subject has history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological disease, or disorder as checked at screening or on admission day (before admission) of period I.
✕. The subject has an evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements, as determined by the principal investigator/clinical sub-investigator at screening or on admission day (before admission) of period I.
✕. The subject has a clinically significant history of skin disorders, including psoriasis or any clinically significant skin abnormality at injection site as checked at screening or on admission day (before admission) of period I.
✕. The subject has a history of any of the following, as checked at screening: Autoimmune disease.
✕.History or presence of significant gastric and/or duodenal ulceration as checked at screening.
✕.The subject has received any vaccination (including influenza) within 60 days prior to first dosing as checked at screening.
✕.The subject used any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing of Period I as checked at screening or on admission day (before admission) of period I.