A RANDOMIZED PHASE I, DOUBLE-BLIND, PARALLEL, COMPARATIVE ASSESSMENT OF PHARMACOKINETICS, SAFETY, PHARMACODYNAMICS, AND IMMUNOGENICITY OF LT-01 (AN OMALIZUMAB BIOSIMILAR CANDIDATE [TEST]) LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION VERSUS EU-APPROVED XOLAIR® LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION (REFERENCE) IN HEALTHY SUBJETCS: CIMA STUDY.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505908-28-00

Acronym

LT-02-19

Enrollment

Registered

2025-01-15

Start date

2025-02-26

Completion date

2025-11-13

Last updated

2025-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic asthma, Chronic rhinosinusitis with nasal polyps, Chronic spontaneous urticaria

None listed

Sex/Gender

All

Age

18 Years to 64 Years

Spain

None listed

Source: EU CTIS · Data processed: Feb 4, 2026