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Phase I Study of VLX-1005 in Healthy Subjects

NCT04783545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-04-28

No results posted yet for this study

Summary

The principal objective of this study is to describe the safety of and tolerability to single and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration.

Other exploratory objectives are:

To evaluate the pharmacokinetics and pharmacodynamics of VLX-1005 following IV administration.

Conditions

  • Safety and Tolerability in Healthy Volunteers

Interventions

DRUG

VLX-1005

VLX-1005 infusion

DRUG

Placebo

Placebo infusion

Sponsors & Collaborators

  • Veralox Therapeutics

    lead INDUSTRY

Principal Investigators

  • Allen Hunt, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2022-01-11
Completion
2022-01-11
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 NCT04783545 on ClinicalTrials.gov