NCT06929052

A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.

An Open Label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single Dose, Subcutaneous Administration, Comparative Pharmacokinetic Study of ADL-018 Injection 150 mg/mL Solution in a Single Dose Pre-filled Autoinjector Compared to ADL-018 Injection 150mg/mL Solution in a Single Dose Pre-filled Syringe in Normal, Healthy, Adult Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Kashiv BioSciences, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

An Open label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single dose, Subcutaneous administration, comparative pharmacokinetic study of ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector compared to ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe in normal, healthy, adult subjects under fasting conditions. The total expected study duration of the clinical part is approximately 127 days from the day of check-in to end study visit. Approximate volume of blood loss in the study will be 150 mL. Handling of Pharmacokinetic Samples After collection, blood samples will be allowed to clot at room temperature for at least 30 to 60 minutes and then will be placed in a refrigerated centrifuge, and then spun at 3000 rpm (± 50 rpm) under refrigeration at 4° C (±2° C) for 10 minutes. The serum will be divided into two aliquots in such a way that the Aliquots#01 (primary aliquot) will contain at least 1.2 mL of serum and the remaining quantity of serum will be transferred into the Aliquots#02 (secondary aliquot) and will be stored in freezer at -70ºC ± 10ºC at the clinical facility until shipment to the analytical facility. The time between the end of centrifugation and placement of samples in the Freezer shall not exceed 45 minutes (+ 15 minutes). The samples will be stored in a freezer at -70ºC ± 10ºC at the analytical facility until analyzed (all the temperature excursions will be handled as per in-house SOP). In case of any processing error due to any reason (e.g. mixing of sample while segregation, mechanical failure in centrifuge, etc.) during the sample processing, re-spun the sample (s) under the same conditions, if required. Note: Transfer of serum samples into the freezer shall take place as soon as possible so the total elapsed time from blood collection to placement of serum samples in the freezer does not exceed 120 minutes. Statistical analyses will be performed on ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Omalizumab using the SAS® software version 9.4 or higher. The pharmacokinetic analysis will include evaluable data from all the subjects who comply with the protocol sufficiently, complete the study and for whom the PK profile can be adequately characterized. The ln-transformed pharmacokinetic parameters e.g. Cmax, AUC0-t and AUC0-∞ will be analyzed using a PROC MIXED effect ANOVA model with the main effect of treatment as fixed effect. A separate ANOVA model will be used to analyze each of the pharmacokinetic parameters. Treatment effects will be tested at the 0.05 level of significance against the residual error (mean square error or MSE) from the ANOVA as the error term. The power of ANOVA test to detect a 20% mean difference between test and reference formulations will be reported. Difference of LSMs will be calculated for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞. The difference will be of the form: Test Product (A) - Reference Product (B). Ratios of means will be expressed in percentage by taking the anti-ln value of difference of LSM. The geometric mean values will be reported. 90% confidence intervals for the difference between investigational product LSMs will be calculated for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ using ln-transformed data. The confidence intervals will be expressed as a percentage relative to the LSM of the reference product. Based on the 90% confidence intervals for the difference of means of lntransformed Pharmacokinetic Parameters Cmax, AUC0-t and AUC0-∞ conclusions will be drawn whether the test product is bioequivalent to the reference product. under fasting condition. The acceptance range for bioequivalence is 80.00-125.00% for the 90% confidence intervals for the difference of means of ln-transformed Cmax, AUC0-t and AUC0-∞ with respect to Omalizumab.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DEVICE	ADL-018 Autoinjector	Test product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector manufactured/supplied by Kashiv BioSciences LLC, USA.
DRUG	ADL-018 Injection	Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured/supplied by Kashiv BioSciences LLC, USA

Timeline

• Start date: 2025-01-29
• Primary completion: 2025-08-15
• Completion: 2025-08-30
• First posted: 2025-04-15
• Last updated: 2026-02-20

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study