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

NCT ID: NCT02840708

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-09-01

Brief Summary

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

Study Design: Pharmacokinetic open study

Detailed Description

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Conditions

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Pulmonary Alveolar Proteinosis, Autoimmune

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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125mcg

SK-1401 125mcg single inhalation

Group Type ACTIVE_COMPARATOR

Sargramostim

Intervention Type DRUG

250mcg

SK-1401 250mcg single inhalation

Group Type ACTIVE_COMPARATOR

Sargramostim

Intervention Type DRUG

500mcg

SK-1401 500mcg single inhalation

Group Type ACTIVE_COMPARATOR

Sargramostim

Intervention Type DRUG

Interventions

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Sargramostim

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Niigata University Medical & Dental Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Niigata University Med & Dental Hospital

Niigata, , Japan

Site Status

Countries

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Japan

Other Identifiers

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NTU

Identifier Type: -

Identifier Source: org_study_id