drugset / Trial / NCT05184218

Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19

NCT05184218 ↗

Phase 1 Terminated 26 enrolled IGM Biosciences, Inc.
RandomizedSequentialDouble-blindTreatment

Summary

This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate COVID-19. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once, or once or twice each day for 5 days.

Timeline

Start
2022-01-20
Primary completion
2022-05-06
Completion
2022-07-04

Outcome

Outcome not reported

Stopped (Business): “Sponsor Decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject IGM-6268 Unknown 1 mg Intranasal
Subject IGM-6268 Unknown 3.75 mg Intranasal
Subject IGM-6268 Unknown 7.5 mg Intranasal

Indications