CompletedPhase 1

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

A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects

Lead sponsor

Mannkind Corporation

Asset

MKC253

Inhaled · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI ≤30•Male•Healthy volunteers

Primary endpoint

•Determine the safety and tolerability of ascending doses of MKC253 Inhalation

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00475371

Org study IDMKC-253-001

Secondary IDEudraCT Number 2007-000361-37

Timeline

Milestones

Study first posted2007-05-21estimated

Last update posted2012-06-14estimated

Study start2007-04 (month precision)

Primary completion2007-06actual (month precision)

Assets

Investigational agents

MKC253

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder

Time frame:2 weeks

descriptive

Secondary/protocol endpoint

Incidence of pulmonary and other AEs

Time frame:2 weeks

event count, event

Secondary/protocol endpoint

Pharmacokinetic (PK) parameters of plasma GLP-1

Time frame:2 weeks

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.