SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study

December 15, 2017 updated by: Niigata University Medical & Dental Hospital

Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation.

Study Design: Pharmacokinetic open study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Niigata, Japan
        • Niigata University Med & Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects judged to be appropriate for the study by the attending physician

  2. can provide signed informed consent.

    aPAP patient must meet the following

  3. aPAP patient aged over 20 and below 80 years old (as of the date of registration)

  4. aPAP severity is mild or moderate. (not severe)

    Healthy volunteer must meet the following

  5. Japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration).
  6. BMI (Body mass index) is between 18 and 25.

Exclusion Criteria:

  1. WBC of 12,000/mcl or more
  2. Fever of 38 degree celsius or more
  3. History of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma)
  4. Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc.
  5. Complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), interstitial pneumonitis, lung fibrosis or bronchiectasis, in which the evaluations of safety of GM-CSF therapy are considered to be difficult.
  6. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
  7. liver dysfunction
  8. renal dysfunction
  9. Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product
  10. Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA
  11. allergic to GM-CSF.
  12. addicted to illegal drugs
  13. Participation to other clinical trials within 12 weeks before registration.
  14. smoking within 5 years

  15. cannot follow the procedure defined in this protocol

    aPAP patient must exclude the following

  16. Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
  17. Patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, GM-CSF or rituximab within 6 months before the start of the study.

  18. taking other inhalation.

    Healthy volunteer must exclude the following

  19. taking any medicines (incl. OTC).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 125mcg
SK-1401 125mcg single inhalation
Drug: Sargramostim
Active Comparator: 250mcg
SK-1401 250mcg single inhalation
Drug: Sargramostim
Active Comparator: 500mcg
SK-1401 500mcg single inhalation
Drug: Sargramostim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum level of Sargramostim
Time Frame: 0.5,1,2,4,8,12 and 24 hours after inhalation
0.5,1,2,4,8,12 and 24 hours after inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niigata University Medical & Dental Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 15, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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