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Safety and Efficacity of NFL101 as Tobacco Therapy

NCT02521701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-14

No results posted yet for this study

Summary

This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.

Conditions

  • Smoking

Interventions

DRUG

NFL101

Level 1: 100 µg * 50 µg per injection (in each arm), two injections at day 1 and two injections at day 29 * The 140 µg must be diluted in 2.8 mL of dilution solution in order to obtain a 50 µg.mL-1 concentration. Level 2: 200 µg * 100 µg per injection (in each arm), two injections at day 1 and two injections at day 29 * The 140 µg must be diluted in 1.4 mL of dilution solution in order to obtain a 100 µg.mL-1 concentration. Therefore, for this level only, two vials are needed to inject 2 x 1.0 mL.

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Anne STOEBNER · ICM Co. Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31
Completion
2016-08-31

Countries

  • France

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 NCT02521701 on ClinicalTrials.gov