A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases

Sponsor
Yuhan Corporation
Study ID
NCT05960708
Phase
PHASE1
Status
Completed

Conditions

  • Allergic Disease
  • Chronic Inducible Urticaria
  • Chronic Spontaneous Urticaria
  • Cold Urticaria

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • YH35324 — DRUG
    Subcutaneous injection of YH35324
  • Omalizumab — DRUG
    Subcutaneous injection of Omalizumab
  • Placebo — DRUG
    Subcutaneous injection of None of active ingredient

Study Details

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.

Key Dates

Start date
Aug 23, 2023
Status verified
Nov 2024
Primary completion
Sep 13, 2024
Completion
Sep 13, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: YH35324
    \[Part 1\] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group. \[Part 2\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. \[Part 3\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.
  • Active Comparator: Omalizumab
    \[Part 1\] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group.
  • Placebo Comparator: Placebo
    \[Part 2\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. \[Part 3\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.

Primary Outcome Measure

Occurrence and severity of adverse events (AEs) [ Time Frame: Occurrence and severity of adverse events will be observed for 57 days after administration ]

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