A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mannkind Corporation
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
Study Overview
Brief Summary
26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit.
Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels.
Detailed Description
This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety & tolerability of MKC253 (GLP1/Technosphere®)Inhalation Powder.
The trial consists of a screening, dosing and a follow-up visit. Single dose administration of MKC253 occurs at the dosing visit. Five doses are being assessed: 0.05, 0.45, 0.75, 1.05 & 1.5 mg GLP-1. Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safety/tolerability data
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy males = 18 and = 45 years of age
- •Written Informed Consent.
- •Body Mass Index (BMI) of < 30 kg/m2
- •Non-smoker
- •Normal pulmonary function and performance on pulmonary function tests
Exclusion Criteria
- •Clinically significant disease including diabetes mellitus
- •Fasting blood glucose > 110 mg/dL (6.1 mmol/L)
- •Significant psychiatric condition or drug or alcohol abuse
- •Any other condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial
- •Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
Arms & Interventions
1
MKC253 Inhalation Powder
Intervention: MKC253 Inhalation Powder (Drug)
Outcomes
Primary Outcomes
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
Time Frame: 2 weeks
Secondary Outcomes
- Incidence of pulmonary and other AEs(2 weeks)
- Pharmacokinetic (PK) parameters of plasma GLP-1(2 weeks)