Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers

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Brief Title

Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers

Official Title

A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Doses of Long Acting HGH Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers

Brief Summary

      The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose
      levels study in healthy Caucasian and Japanese male volunteers.

      Following a 4-week screening period, eligible male subjects will be stratified by ethnic
      group and will be randomized to one of six groups. On dosing day, designated as Day 1, each
      subject will receive single SC injection of study medication according to group allocation
      and will be followed up for a month for safety monitoring.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions

Secondary Outcome

 Pharmacodynamic (PD) profile (IGF-1 and IGFBP-3 levels) to MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose

Condition

Growth Hormone Deficiency

Intervention

MOD-4023

Study Arms / Comparison Groups

 Low dose
Description:  7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

42

Start Date

January 2015

Completion Date

June 2015

Primary Completion Date

March 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Healthy male volunteers, 18 to 45 years of age (inclusive).

          2. Body Mass Index (BMI) 18 to 30 kg/m2 (inclusive) and weighing at least 55 kg.

          3. Subjects in generally good health in the opinion of the investigator as determined by
             medical history, vital signs and a physical examination.

          4. Blood pressure and heart rate within normal limits.

          5. Electrocardiogram (ECG) with no clinically significant abnormalities recorded at
             screening visit (up to 28 days before dosing) and on dosing day (before drug
             administration).

          6. Negative HIV, hepatitis B and hepatitis C serology tests at screening

          7. No clinically significant abnormalities in complete blood count (CBC), international
             normalized ratio (INR), chemistry lab tests (liver and renal function) and urinalysis
             at screening.

          8. No history of alcohol or drug abuse within 1 year of screening. Negative urine
             drugs-of-abuse (DOA) in screening and on admission. Negative breath alcohol on
             admission.

          9. Subjects must agree to use medically accepted form of contraception from dosing day to
             12 weeks after drug administration.

         10. Subjects must be able to understand the requirements of the study and must be willing
             to comply with the requirements of the study and to provide their written informed
             consent to participate in the study.

        Exclusion Criteria:

          1. History of significant neurological (including history of seizures or EEG
             abnormalities), renal, cardiovascular (including known structural cardiac
             abnormalities or hypertension), respiratory (asthma), endocrinological,
             gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety,
             tension or agitation) or any other clinically significant medical disorder, which in
             the investigator's judgment contraindicate administration of the study medication.

          2. Known allergy to growth hormone or any constituents or ingredients or components in
             the vehicle.

          3. Adherence (for whatever reason) to an abnormal diet (including any dietary
             restrictions, e.g. low fat, lactose-free, low sodium, high protein, gluten-free,
             organic, etc.) during the 4 weeks prior to the study, or subjects with recent
             significant change in body weight.

          4. Use of any prescription or over-the-counter (OTC) medications, including vitamins and
             herbal or dietary supplements within 14 days prior to dosing. Brief use of OTC
             medications for symptomatic relief of pain until 24 hours prior to and 48 hours after
             the study drug administration may be allowed per the discretion of the medical
             monitor.

          5. Subjects who have received any vaccines within 4 weeks prior to study drug
             administration.

          6. Subjects who donated blood or received blood or plasma derivatives in the one month
             preceding signing of consent form.

          7. Systemic corticosteroids other than in replacement doses within the 3 months before
             study entry (temporary adjustment of glucocorticoids, as appropriate, is acceptable)

          8. Anabolic steroids other than gonadal steroid replacement therapy within 2 months
             before study entry

          9. Participation in another clinical trial with drugs within one month of signing of
             consent form (calculated from the previous study's last dosing date).

         10. Subjects with an inability to communicate well with the investigators and clinic staff
             [i.e., language problem (except Japanese speakers), poor mental development or
             impaired cerebral function].

         11. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of
             study start, which is considered of significance by the Principal Investigator. Use of
             investigational products (within 30 days of screening visit).
      

Gender

Male

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02418767

Organization ID

CP-4-007


Responsible Party

Sponsor

Study Sponsor

OPKO Health, Inc.

Collaborators

 WCCT Global

Study Sponsor

, , 


Verification Date

September 2019