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

NCT ID: NCT02418767

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose

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

Group Type: EXPERIMENTAL

MOD-4023

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Mid dose

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

Group Type: EXPERIMENTAL

MOD-4023

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

High dose

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

Group Type: EXPERIMENTAL

MOD-4023

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

MOD-4023

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

WCCT Global

INDUSTRY

Sponsor Role: collaborator

OPKO Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

WCCT Global

Cypress, California, United States

Countries

United States

Other Identifiers

CP-4-007

Identifier Type: -

Identifier Source: org_study_id