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- || lesigercept (GI-301) / Yuhan Corp
Trial completion: A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases (clinicaltrials.gov) - Dec 5, 2024
P1, N=46, Completed, Sponsor: Yuhan Corporation
Active, not recruiting --> Completed
- || lesigercept (GI-301) / Yuhan Corp
Trial completion: A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases (clinicaltrials.gov) - Sep 25, 2024
P1, N=30, Completed, Sponsor: Yuhan Corporation
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || lesigercept (GI-301) / Yuhan Corp
Enrollment closed: A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases (clinicaltrials.gov) - Sep 19, 2024
P1, N=30, Active, not recruiting, Sponsor: Yuhan Corporation
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || lesigercept (GI-301) / Yuhan Corp
Enrollment closed: A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases (clinicaltrials.gov) - Aug 2, 2024
P1, N=46, Active, not recruiting, Sponsor: Yuhan Corporation
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | lesigercept (GI-301) / Yuhan Corp
Phase classification, Trial completion date, Trial primary completion date: A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases (clinicaltrials.gov) - Jun 23, 2024
P1, N=43, Recruiting, Sponsor: Yuhan Corporation
Recruiting --> Active, not recruiting Phase classification: P1b --> P1 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- | lesigercept (GI-301) / Yuhan Corp
Trial completion date, Trial primary completion date: A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases (clinicaltrials.gov) - Apr 22, 2024
P1, N=36, Recruiting, Sponsor: Yuhan Corporation
Phase classification: P1b --> P1 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Mar 2024 --> Aug 2024
- GI-301 / GI Innovation, Yuhan Corp
Therapeutic efficacy of YH35324 on Fc?RI?-mediated mast cell activation (E-TPS Display Only Digital section) - Apr 21, 2024 - Abstract #EAACI2024EAACI_1219;
was significantly higher in the YH-administration group than in the Oma-administered group, while no differences were noted in serum levels of soluble CD23 and MRGPRX2 between the two groups. Conclusion These findings suggest that YH can be a new therapeutic option for IgE-mediated allergic disease.
- || GI-301 / GI Innovation, Yuhan Corp
Clinical, P1 data, PK/PD data, Journal: Safety, Tolerability, Pharmacokinetics, and pharmacodynamics of YH35324, a novel Long-Acting High-Affinity IgETrap-Fc protein in subjects with Atopy: Results from the First-in-Human study. (Pubmed Central) - Mar 25, 2024
Conclusion These findings suggest that YH can be a new therapeutic option for IgE-mediated allergic disease. This study showed that YH35324 has a favorable safety profile and is effective in reducing serum-free IgE levels in subjects with atopic conditions.
- || lesigercept (GI-301) / Yuhan Corp
New P1 trial: A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases (clinicaltrials.gov) - Jul 27, 2023
P1, N=36, Recruiting, Sponsor: Yuhan Corporation
- GI-301 / GI Innovation, Yuhan Corp
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YH35324, a Novel Long-Acting High-Affinity IgETrap-Fc protein in Subjects with Atopy: Results from the First-in-Human Study (Poster Zone C) - Apr 30, 2023 - Abstract #EAACI2023EAACI_1143;
YH35324 rapidly suppressed serum free IgE level to a greater extent than omalizumab. Median duration of serum-free IgE concentration maintained at < 82.8 ng/mL increased with increasing dose of YH35342 and were longer in all YH35324 dose groups than in the omalizumab and placebo groups (P<0.05).
- ||| lesigercept (GI-301) / Yuhan Corp
Trial completion: A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases (clinicaltrials.gov) - Jan 27, 2023
P1, N=68, Completed, Sponsor: Yuhan Corporation
Median duration of serum-free IgE concentration maintained at < 82.8 ng/mL increased with increasing dose of YH35342 and were longer in all YH35324 dose groups than in the omalizumab and placebo groups (P<0.05). Active, not recruiting --> Completed
- || lesigercept (GI-301) / Yuhan Corp
Enrollment closed: A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases (clinicaltrials.gov) - Oct 13, 2022
P1, N=68, Active, not recruiting, Sponsor: Yuhan Corporation
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || lesigercept (GI-301) / Yuhan Corp
New P1 trial: A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases (clinicaltrials.gov) - Oct 3, 2022
P1b, N=34, Recruiting, Sponsor: Yuhan Corporation
- | GI-301 / GI Innovation, Yuhan Corp
Journal: Detection of serum IgG autoantibodies to FcεRIα by ELISA in patients with chronic spontaneous urticaria. (Pubmed Central) - Aug 28, 2022
Recruiting --> Active, not recruiting This study confirmed the presence of IgG to FcεRIα in the sera of CSU patients, especially those with the autoimmune phenotype.
- GI-301 / GI Innovation, Yuhan Corp
The measurement of serum IgG autoantibody to FcεRI by ELISA in chronic spontaneous urticaria (CSU) () - Apr 30, 2022 - Abstract #EAACI2022EAACI_647;
Method Eighty-eight patients with CSU and 76 healthy controls (HCs) were enrolled. To detect circulating IgG to FcεRIα level by ELISA, the novel IgETRAP called YH35324 was used to bind to the FcεRIα site of each serum autoantibodies including IgG...No significant associations were found between the presence of IgG antibodies and sex, age, atopy, urticaria duration, UAS, or serum total/free IgE levels. Conclusion The present study confirmed the presence of circulating autoantibodies, IgG to FcεRIα in sera of CSU patients, especially in the patients related to autoimmunity.
- ||| lesigercept (GI-301) / Yuhan Corp
New P1 trial: A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases (clinicaltrials.gov) - Sep 28, 2021
P1, N=68, Recruiting, Sponsor: Yuhan Corporation