Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT05160402
Status:
TERMINATED
Last Update Posted:
2022-10-14
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of IGM-6268 in Healthy Volunteers
Sponsor:
IGM Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single (SAD) and multiple ascending (MAD) ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once (SAD), or once or twice each day for 5 days (MAD).
Detailed Description:
IGM-6268 is an engineered Immunoglobulin M (IgM) antibody that specifically targets the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. This humanized pentameric IgM antibody has 10 binding sites to the spike protein and a J-chain to enable the formation of IgM pentamers.
IGM-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate COVID-19. The primary mechanism of action of IGM-6268 is to block the binding of the SARS-CoV-2 RBD on the spike protein to human angiotensin converting enzyme 2 (hACE2), the cellular receptor for SARS-CoV-2. By blocking this binding, IGM 6268 neutralizes the infectivity of the virus.
IGM-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate COVID-19. The primary mechanism of action of IGM-6268 is to block the binding of the SARS-CoV-2 RBD on the spike protein to human angiotensin converting enzyme 2 (hACE2), the cellular receptor for SARS-CoV-2. By blocking this binding, IGM 6268 neutralizes the infectivity of the virus.
Study Oversight
Has Oversight DMC:
True
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?: