A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases

• Status: Recruiting
• Trial end date: 2022-12-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo group, or the omalizumab group.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• 19~55 years old, Atopic Healthy Subjects or Subjects With Mild Allergic Diseases

• Serum total IgE level of 30 to 700 IU/mL or > 700 IU/mL

• Signed the informed consent form

Exclusion Criteria:

• Hyperimmunoglobulin E syndrome or malignancy

• Positive drug screen result

• AST or ALT > 1.5 * Upper normal range

• eGFR < 60mL/min/1.73m2

• Allergy immunotherapy initiated or Administration of a live vaccine within 3 months prior to randomization

• History of participation in another clinical trial within 6 months prior to randomization