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Trial · NCT05061524

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

NCT05061524, Phase 1, Completed, Yuhan Corporation

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases. Trials, record NCT05061524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05061524

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
NCT number
NCT05061524
Status
Completed
Phases
Phase 1
Enrollment
68 participants, actual
Lead sponsor
Yuhan Corporation
Conditions
Atopic Healthy Subjects, Adult Subjects with Mild Allergic Diseases
Interventions
YH35324, Placebo, Omalizumab
First posted
2021-09-29
Last updated
2024-12-03

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTo evaluate the safety and tolerability following single administration of YH35324Occurrence and severity of adverse events will be observed for 113 days after administrationOccurrence and severity of adverse events (AEs)
SecondaryTo evaluate the PK of YH35324Serum concentrations of YH35324 will be observed for 113 days after administrationSerum concentrations of YH35324
SecondaryTo evaluate the PD of YH35324Change in serum Free/Total IgE level will be observed for 113 days after administrationChange in serum Free/Total IgE level
OtherTo explore the PD of YH35324Changes in FcεRI expression will be observed for 57days after administrationChanges in FcεRI expression
OtherTo explore inhibition on allergens (allergy antigens) of YH35324Changes in allergen-induced skin prick wheal response will be observed for 57 days after administrationChanges in allergen-induced skin prick wheal response
OtherTo explore the immunogenicity of YH35324Incidence of serum Anti-YH35324 antibodies will be observed for 113 Days after administrationIncidence of serum Anti-YH35324 antibodies
OtherTo explore inhibition on allergens (allergy antigens) of YH35324Changes in allergen-induced serum allergen specific IgE level will be observed for 57 days after administrationChanges in serum allergen specific IgE level

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05061524

GET https://conductscience.org/api/trials/v1/NCT05061524/registered