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Safety, Tolerability & Pharmacokinetics of LEVI-04 in Healthy Volunteers and Patients With Osteoarthritis Knee Pain

NCT03227796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-04-08

No results posted yet for this study

Summary

This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain attributed to osteoarthritis of the knee)

Conditions

Interventions

DRUG

LEVI-04

LEVI-04 intravenous infusion

DRUG

Placebo

Placebo intravenous infusion

Sponsors & Collaborators

  • Hammersmith Medicines Research

    collaborator OTHER

  • MAC Clinical Research

    collaborator OTHER

  • Levicept

    lead INDUSTRY

Principal Investigators

  • Denisa Wilkes, MUDr · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United Kingdom

Study Locations

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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 NCT03227796 on ClinicalTrials.gov