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

NCT05184218 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

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 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.

Conditions

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
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

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

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05184218 on ClinicalTrials.gov