PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects

Sponsor
Kashiv BioSciences, LLC
Study ID
NCT05564611
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Omalizumab 150mg — DRUG
    A single dose of 150 mg lyophilized vial will be administered in the upper arm as the site of injection

Study Details

This will be a randomized, double blind, two-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. Total 204 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 204 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.

Key Dates

Start date
Nov 4, 2022
Status verified
Feb 2025
Primary completion
Jul 30, 2023
Completion
Aug 15, 2023

Study Design

Enrollment
204 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: ADL-018
    150 mg single dose Lyophilized vial
  • Active Comparator: US-Licensed XOLAIR
    150 mg single dose Lyophilized vial

Primary Outcome Measure

Pharmacokinetic Outcome Measures [Cmax] [ Time Frame: Upto Day 85] [ Time Frame: Upto Day 85 ]

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