Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-13 @ 3:45 AM
Study NCT ID:
NCT05449535
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2022-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
Sponsor:
Jemincare
Organization:
Study Overview
Official Title:
Phase Ia Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Preliminary Pharmacodynamics, and Immunogenicity of Single-dose JYB1904 in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.
Detailed Description:
This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.
The sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).
Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.
The sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).
Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTR20220973 | REGISTRY | National Medical Products Administration of China | View |