A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in H… (NCT06929052) | Clinical Trial Compass
CompletedPhase 1
A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.
Canada150 participantsStarted 2025-01-29
Plain-language summary
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects. and also to assess safety and tolerability of investigational product.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age: 18 to 65 years of age, inclusive, at the time of dosing.
✓. Subject should be having serum total IgE ≤ 100 IU/ml at the time of screening
✓. Gender: Male and/or non-pregnant, non-lactating female. Female of childbearing potential must have a negative serum pregnancy test performed within 28 days prior to dosing day.
✓. Male subjects and/or female subject's partner must agree to use acceptable form of contraception which includes vasectomy, or use condoms, or spermicide in addition to female contraception for additional protection against conception from screening until 156 days after administration of the study medication.
✓. For female of childbearing potential, must agree to use acceptable forms of contraception from screening until 156 days after administration of the
✓. BMI: 18.5 to 32.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g., 32.04 rounds down to 32.0, while 18.49 rounds up to 18.5).
✓. Volunteers having body weight ≥50.0 kg or ≤ 90.0 kg.
✓. Able to communicate effectively with study personnel.
Exclusion criteria
✕. History of allergic responses to study drug or other related drugs, or any of its formulation ingredients.
✕. History of allergic reactions or sensitivity to latex or latex derived products.
. Have significant diseases or clinically significant abnormal findings during screening \[medical history, comprehensive physical examination, vital signs, laboratory evaluations and ECG\].
✕. Any disease or condition like diabetes, psychosis or others, which might compromise the hemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
✕. History of helminthic or parasitic infection.
✕. History of immunological disorders or presence of bronchial asthma.
✕. Use of any hormone replacement therapy within 3 months prior to the study medication administration.
✕. Use of any depot injection or implant of any drug within 3 months prior to the study medication administration.