A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mannkind Corporation

Criteria

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