Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT05413161
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2022-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects
Sponsor:
Kashiv BioSciences, LLC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTRI/2022/06/043399 | OTHER | CTRI | View |