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Evaluation of IGM-6268 in Healthy Volunteers

NCT05160402 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-10-14

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

DRUG

IGM-6268

Active comparator

DRUG

Placebo

Placebo comparator

Sponsors & Collaborators

  • IGM Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Roel Funke · IGM Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-06-15
Completion
2022-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05160402 on ClinicalTrials.gov