Clinical trial NCT02302443: A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470
Official title: A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Administration of HM12470 in Subjects With Type 1 (T1DM) and Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.

Detailed description: This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.

Eligibility criteria: Inclusion Criteria for T1DM:

* T2DM more than 12 monthM
* Age ≥18 and ≤70 years
* Body mass index between 18.0 and 35.0 kg/m2 inclusive.
* Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Inclusion Criteria for T2DM:

* T1DM more than 12 monthM
* Age ≥18 and ≤70 years
* Body mass index between 18.0 and 30.0 kg/m2 inclusive.
* Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Exclusion Criteria

* A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
* Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
* pregnant or lactating women
* participation in an investigational study within 30 days prior to dosing
* Clinically significant abnormal ECG at screening, as judged by the Investigator

Primary outcomes:
measure: Incidence and severity of treatment emergent adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Peak Plasma Concentration(Cmax) of HM12470 following a single dose
timeFrame: 1 month
measure: Area under the concentration-time curve (AUC) of HM12470 following a single dose
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Pharmaceutical Company
Study officials:
affiliation: Hanmi Pharmaceuticals
name: Hanmi Pharmaceuticals Hanmi Pharmaceuticals
role: STUDY_DIRECTOR
References: