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

NCT05564611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-02-05

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Omalizumab 150mg

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

Sponsors & Collaborators

  • Kashiv BioSciences, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-07-30
Completion
2023-08-15
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564611 on ClinicalTrials.gov