Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02418767 |
Date of registration:
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08/01/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
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Scientific title:
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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 |
Date of first enrolment:
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January 2015 |
Target sample size:
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42 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02418767 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: MOD-4023
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Drug: Placebo
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Primary Outcome(s)
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Pharmacokinetics (PK) profile of MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose
[Time Frame: 7 days]
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Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
[Time Frame: 30 days]
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Secondary Outcome(s)
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Pharmacodynamic (PD) profile (IGF-1 and IGFBP-3 levels) to MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose
[Time Frame: 14 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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