| Trial ID: | L3497 |
| Source ID: | NCT01724814
|
| Associated Drug: |
Hm12460a
|
| Title: |
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A
|
| Acronym: |
HM12460A
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy|Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: HM12460A|DRUG: Placebo
|
| Outcome Measures: |
Primary: Incidence and severity of treatment emergent adverse events, one year | Secondary: Peak Plasma Concentration(Cmax) of HM12460A following a single dose in Parts 1-3, PK properties of HM12460A following a single dose in Parts 1-3 will be assessed in plasma using a validated assay, one year
|
| Sponsor/Collaborators: |
Sponsor: Hanmi Pharmaceutical Company Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
86
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-12-20
|
| Completion Date: |
2014-07-01
|
| Results First Posted: |
|
| Last Update Posted: |
2017-11-08
|
| Locations: |
Hanmi pharma, Chula Vista, California, 91911, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01724814
|
