drugset / Trial / NCT05184218
Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IGM-6268 | Unknown | 1 mg | Intranasal |
| Subject | IGM-6268 | Unknown | 3.75 mg | Intranasal |
| Subject | IGM-6268 | Unknown | 7.5 mg | Intranasal |