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

Pulmonary Alveolar Proteinosis, Autoimmune Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840708
• Other study ID #: NTU
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2016
• Last updated: December 15, 2017
• Start date: May 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: December 2017
• Source: Niigata University Medical & Dental Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Study Design: Pharmacokinetic open study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 1, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autoimmune Diseases
• Pulmonary Alveolar Proteinosis
• Pulmonary Alveolar Proteinosis, Autoimmune
• Respiratory Aspiration

Intervention

Drug:
• Sargramostim

Locations

Country	Name	City	State
Japan	Niigata University Med & Dental Hospital	Niigata

Sponsors (1)

Lead Sponsor	Collaborator
Niigata University Medical & Dental Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of Sargramostim		0.5,1,2,4,8,12 and 24 hours after inhalation