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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00475371

Enrollment

Registered

2007-05-21

Start date

2007-04-30

Completion date

Unknown

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Healthy Males

Keywords

Healthy, Diabetes Mellitus: Type II

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/TechnosphereÂ®)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

Interventions

DRUGMKC253 Inhalation Powder

Inhalation powder

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder	2 weeks

Secondary

Measure	Time frame
Incidence of pulmonary and other AEs	2 weeks
Pharmacokinetic (PK) parameters of plasma GLP-1	2 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026