Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-28 @ 4:53 AM
Study NCT ID:
NCT06911866
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib Study of RC1416 Injection
Sponsor:
Nanjing RegeneCore Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of RC1416 Injection in Patients With Moderate to Severe Asthma
Status:
RECRUITING
Status Verified Date:
2025-03
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 is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RC1416 injection in patients with moderate to severe asthma.
Detailed Description:
This study is a randomized, double-blind, placebo-controlled, ascending dose Phase Ib clinical study. RC1416 is a bispecific antibodies .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 40 patients with moderate to severe asthma will be enrolled in 4 groups to access the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of RC1416 injection.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: