drugset / Trial / NCT05413161

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

NCT05413161

Phase 1 Completed 306 enrolled Kashiv BioSciences, LLC
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2022-07-07
Primary completion
2023-02-21
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ADL-018 Unknown Subcutaneous
Comparator Omalizumab Monoclonal antibody Subcutaneous

Indications

No indication recorded.