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A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A

This study is currently recruiting participants.
Verified March 2013 by Hanmi Pharmaceutical Company Limited
Sponsor:
Collaborator:
Profil Institute for Clinical Research, Inc.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01724814
First received: November 5, 2012
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

Study Design:

Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1 diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes


Condition Intervention Phase
Healthy
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
 Drug: HM12460A
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Incidence and severity of treatment emergent adverse events [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak Plasma Concentration(Cmax) of HM12460A following a single dose in Parts 1-3 [ Time Frame: one year ] [ Designated as safety issue: No ]
    PK properties of HM12460A following a single dose in Parts 1-3 will be assessed in plasma using a validated assay


Estimated Enrollment: 48
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort S1
HM12460A Dose 1 (1.2 nmol/kg) or placebo
 Drug: HM12460A
Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
Other Name: LAPS-Insulin
Drug: Placebo
Singe dose SC administration of Placebo
Experimental: Cohort S2
HM12460A Dose 2 (2.4 nmol/kg) or Placebo
 Drug: HM12460A
Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
Other Name: LAPS-Insulin
Drug: Placebo
Singe dose SC administration of Placebo
Experimental: Cohort S3
HM12460A Dose 3 (4.8 nmol/kg) or Placebo
 Drug: HM12460A
Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
Other Name: LAPS-Insulin
Drug: Placebo
Singe dose SC administration of Placebo
Experimental: Cohort S4
HM12460A Dose 4 (9.6 nmol/kg) or Placebo
 Drug: HM12460A
Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
Other Name: LAPS-Insulin
Drug: Placebo
Singe dose SC administration of Placebo
Experimental: Cohort S5
HM12460A Dose 5 (14.4 nmol/kg) or Placebo
 Drug: HM12460A
Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
Other Name: LAPS-Insulin
Drug: Placebo
Singe dose SC administration of Placebo
Experimental: Cohort S6
HM12460A Dose 6 (19.2 nmol/kg) or Placebo
 Drug: HM12460A
Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
Other Name: LAPS-Insulin
Drug: Placebo
Singe dose SC administration of Placebo

Detailed Description:

The principle objectives of this study are to assess safety and tolerability and to explore pharmacokinetic(PK) and pharmacodynamic(PD) parameters of a single dose of a novel very-long acting insulin formulation (HM12460A) in comparison to a single dose of human Neutral Protamine Hagedorn (NPH) in healthy volunteers (part 1), subjects with type 1 diabetes (part 2) and in subjects with type 2 diabetes (part 3).

The study will incorporate adaptive elements to provide both PK and PD data. The dose of HM12460A to be administered to the subjects with type 1 diabetes and type 2 diabetes will be guided by PK data from part 1 of the study; the PD assessment of HM12460A in subjects with diabetes will also be informed by knowledge of PK gained from the healthy volunteer study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy subjects

  • Age ≥18 and ≤70 years
  • Non-obese; 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.
  • Non-smoker, or light smoker, defined as <15 cigarettes/day and able to abstain from smoking during confinement period.
  • 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:

  • Previous participation in this trial or other clinical trials within the last 3 months.
  • Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, healthy subjects with liver enzymes above the upper limit of the normal range and subjects with diabetes who have elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will be excluded.
  • History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
  • Clinically significant abnormal ECG at screening, as judged by the Investigator.
  • History of alcohol abuse.
  • Any positive reaction of drugs of abuse.
  • Hepatitis B or C or HIV positive.
  • Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for medications deemed acceptable per protocol specific list of concomitant medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724814

Contacts
Contact: Denon Alderson 866-308-7427 volunteer@profilinstitute.com

Locations
United States, California
Profil Institute for Clinical Research, Inc. Recruiting
Chula Vista, California, United States, 91911
Contact: Denon Alderson     866-308-7427     volunteer@profilinstitute.com    
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Profil Institute for Clinical Research, Inc.
Investigators
Principal Investigator: Marcus Hompesch, Dr. Profil Institute for Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01724814     History of Changes
Other Study ID Numbers: HM-INS-101
Study First Received: November 5, 2012
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013