drugset / Trial / NCT05564611

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

NCT05564611

Phase 1 Completed 204 enrolled Kashiv BioSciences, LLC
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2022-11-04
Primary completion
2023-07-30
Completion
2023-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 150 mg Subcutaneous

Indications

No indication recorded.