drugset / Trial / NCT05564611
PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 150 mg | Subcutaneous |
Indications
No indication recorded.