NCT05413161

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

A Randomized, Double Blind, Three-arm, Parallel Group, Single Dose Comparative PK, PD, Safety and Immunogenicity Study Comparing ADL-018 With US-licensed XOLAIR and EU-Approved XOLAIR in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Kashiv BioSciences, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. Total 306 healthy, adult, eligible human subjects (102 in each treatment arm) will be enrolled in the study with their consent. Required \*standby subjects will also be enrolled to ensure that 306 subjects are dosed in the study. The study will be conducted in cohorts; all the study procedures will be identical as mentioned in the protocol for all the cohorts.

Detailed description

This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. The study objectives will be to compare the pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate safety and immunogenicity of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EU-APPROVED XOLAIR following single subcutaneous dose in healthy adult subjects. For the purpose of this study the following eligibility assessments will be carried out before enrollment / during the study of any volunteer in the study. Assessment criteria should be fulfilled for volunteers to be enrolled in the study. The screening will be carried out only after taking written informed consent from volunteers. Once the subject becomes eligible, will get randomized to receive either ADL-018, US-licensed XOLAIR or EU approved XOLAIR as per the randomization schedule. This will be parallel design so will have only one study period. After dosing, all subjects will go for serial PK sampling as defined in the study protocol. All subjects will be monitored on safety grounds as mentioned in the study protocol.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	ADL-018	150 mg/mL, Solution for injection in PFS
BIOLOGICAL	US-licensed XOLAIR	150 mg/mL, Solution for injection in PFS
BIOLOGICAL	EU-Approved XOLAIR	150 mg/mL, Solution for injection in PFS

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-02-21
• Completion: 2023-06-30
• First posted: 2022-06-09
• Last updated: 2023-07-03

Locations

2 sites across 1 country: India

Regulatory

• FDA-regulated drug study