A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

Yuhan

Status and phase: Completed; Phase 1

Conditions: Adult Subjects With Allergic Diseases; Atopic Healthy Subjects

Treatments: Drug: YH35324; Drug: Placebo; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05564221

YH35324-102

Details and patient eligibility

About

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have atopy.

Full description

YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine release caused by degranulation when exposed to allergens. This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have atopy.

Enrollment: 46 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female adults aged ≥ 19 to ≤ 55 years(Cohort 5, Mald or female adults ≥ 19)
• Serum total IgE level ≥ 30 IU/mL or 30 to 700 IU/mL or >700IU/mL(Not Applicable for Cohort 5)
• Meeting the following cohort-specific disease severity criteria [Cohorts 1-4]: Healthy subjects without any pathological symptoms or findings from medical examination, or subjects with a history of mild allergic diseases (allergic rhinitis, atopic dermatitis, food allergy, urticaria, or allergic asthma) [Cohort 5]: Subject who have been diagnosed with moderate to severe atopic dermatitis

Exclusion criteria

• History of malignancy
• Positive drug screen result
• transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal
• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
• Allergy immunotherapy initiated or changed within 6 months prior to randomization(For Cohort 5, within 12 months prior to randomization)
• History of participation in another clinical trial within 6 months prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups, including a placebo group

YH35324

Experimental group

Description:

There will be 5 dose groups of YH35324, escalating from low to high doses in a stepwise manner: Cohort 1(A mg/kg) → Cohort 2(B mg/kg) → Cohorts 3(C mg/kg) and 4(C mg/kg) → Cohort 5(C mg/kg) YH35324 and placebo will be administered in a double-blinded manner.

Treatment:

Drug: YH35324

Placebo

Placebo Comparator group

Description:

There will be 5 dose groups of YH35324, escalating from low to high doses in a stepwise manner: Cohort 1(A mg/kg) → Cohort 2(B mg/kg) → Cohorts 3(C mg/kg) and 4(C mg/kg) → Cohort 5(C mg/kg) YH35324 and placebo will be administered in a double-blinded manner.

Treatment:

Drug: Placebo

Omalizumab

Active Comparator group

Description:

For Cohort 3, omalizumab 300 mg will be administered in an open-label manner.

Treatment:

Drug: Omalizumab