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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the safety and tolerability following single administration of YH35324 | Occurrence and severity of adverse events will be observed for 113 days after administration | Occurrence and severity of adverse events (AEs) |
| Secondary | To evaluate the PK of YH35324 | Serum concentrations of YH35324 will be observed for 113 days after administration | Serum concentrations of YH35324 |
| Secondary | To evaluate the PD of YH35324 | Change in serum Free/Total IgE level will be observed for 113 days after administration | Change in serum Free/Total IgE level |
| Other | To explore the PD of YH35324 | Changes in FcεRI expression will be observed for 57days after administration | Changes in FcεRI expression |
| Other | To explore inhibition on allergens (allergy antigens) of YH35324 | Changes in allergen-induced skin prick wheal response will be observed for 57 days after administration | Changes in allergen-induced skin prick wheal response |
| Other | To explore the immunogenicity of YH35324 | Incidence of serum Anti-YH35324 antibodies will be observed for 113 Days after administration | Incidence of serum Anti-YH35324 antibodies |
| Other | To explore inhibition on allergens (allergy antigens) of YH35324 | Changes in allergen-induced serum allergen specific IgE level will be observed for 57 days after administration | Changes in serum allergen specific IgE level |
Source ClinicalTrials.gov
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.
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