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A First-in-Human Study of AV-001 in Healthy Subjects

NCT04737486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-03-24

No results posted yet for this study

Summary

Phase 1 randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) first-in-human study in healthy subjects. Safety and tolerability assessments will be conducted, and blood samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK) and pharmacodynamics (PD) analysis.

Conditions

  • Covid19-associated ARDS
  • Covid19
  • ARDS

Interventions

DRUG

AV-001

AV-001 (mpaBr) Cl for Injection 2.5 mg/mL

OTHER

Placebo

D-PBS

Sponsors & Collaborators

  • Vasomune Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Leela Vrishabhendra, MD · Medpace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2021-03-10
Completion
2021-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04737486 on ClinicalTrials.gov