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A

Asan Medical Center | Clinical Trial Center

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

Y

Yuhan

Status and phase

Enrolling
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

43 estimated 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

43 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

Trial contacts and locations

9

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Central trial contact

JungWook Ahn; Jungwook Lee

Data sourced from clinicaltrials.gov

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