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Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer

NCT02654938 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-09-20

No results posted yet for this study

Summary

Phase I single-blinded, randomized, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of single injections of ascending doses of investigational drug product Mobilan (М-VM3) administered directly into the prostate of patients with prostate cancer.

Conditions

Interventions

DRUG

Mobilan (M-VM3)

Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.

DRUG

Placebo

5% infusion solution of dextrose

Sponsors & Collaborators

  • Panacela Labs LLC

    lead INDUSTRY

Principal Investigators

  • Vsevolod B. Matveev, MD, PhD · Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences

  • Boris Y. Alexeev, MD, PhD · Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation

  • Vladimir M. Moiseenko, MD, PhD · Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"

  • Sergey V. Mishugin, MD, PhD · Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department

  • Alexander K. Nosov, MD, PhD · Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation

  • Dmitry Y. Pushkar, MD, PhD · Moscow State University of Medicine and Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Russia

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 NCT02654938 on ClinicalTrials.gov