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

NCT02840708 | Completed Phase 1

• 1 other identifier: NTU
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation. Study Design: Pharmacokinetic open study

Conditions

Pulmonary Alveolar Proteinosis, Autoimmune

Outcome Measures

Primary Outcomes (1)

• Serum level of Sargramostim

  0.5,1,2,4,8,12 and 24 hours after inhalation

Study Arms (3)

125mcg

ACTIVE COMPARATOR

SK-1401 125mcg single inhalation

Drug: Sargramostim

250mcg

ACTIVE COMPARATOR

SK-1401 250mcg single inhalation

Drug: Sargramostim

500mcg

ACTIVE COMPARATOR

SK-1401 500mcg single inhalation

Drug: Sargramostim

Interventions

Sargramostim DRUG

125mcg; 250mcg; 500mcg

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects judged to be appropriate for the study by the attending physician
• can provide signed informed consent.
• aPAP patient must meet the following
• aPAP patient aged over 20 and below 80 years old (as of the date of registration)
• aPAP severity is mild or moderate. (not severe)
• Healthy volunteer must meet the following
• Japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration).
• BMI (Body mass index) is between 18 and 25.

You may not qualify if:

• WBC of 12,000/mcl or more
• Fever of 38 degree celsius or more
• History of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma)
• Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc.
• 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.
• History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
• liver dysfunction
• renal dysfunction
• Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product
• Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA
• allergic to GM-CSF.
• addicted to illegal drugs
• Participation to other clinical trials within 12 weeks before registration.
• smoking within 5 years
• cannot follow the procedure defined in this protocol

Sponsors & Collaborators

• Niigata University Medical & Dental Hospital: lead

Study Sites (1)

Niigata University Med & Dental Hospital

Niigata, Japan

Location

MeSH Terms

Conditions

Pulmonary Alveolar Proteinosis, Acquired

Interventions

sargramostim

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 21, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: September 1, 2017
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

JP (1)