drugset / Trial / NCT05160402
Evaluation of IGM-6268 in Healthy Volunteers
RandomizedSequentialDouble-blindOther
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).
Timeline
- Start
- 2021-12-07
- Primary completion
- 2022-06-15
- Completion
- 2022-08-18
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 |
Indications
No indication recorded.