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

NCT02418767 | Completed Phase 1

• 1 other identifier: CP-4-007
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  To assess the safety, tolerability and immunogenicity of MOD-4023 in healthy Caucasian and Japanese subjects after single subcutaneous (SC) dose.

  30 days

• Pharmacokinetics (PK) profile of MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose

  MOD-4023 serum levels (T1/2, Area-Under-the-Curve, Cmax, Tmax)

  7 days

Secondary Outcomes (1)

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

  14 days

Study Arms (3)

Low dose

EXPERIMENTAL

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

Drug: MOD-4023; Drug: Placebo

Mid dose

EXPERIMENTAL

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

Drug: MOD-4023; Drug: Placebo

High dose

EXPERIMENTAL

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

Drug: MOD-4023; Drug: Placebo

Interventions

MOD-4023 DRUG

High dose; Low dose; Mid dose

Placebo DRUG

High dose; Low dose; Mid dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers, 18 to 45 years of age (inclusive).
• Body Mass Index (BMI) 18 to 30 kg/m2 (inclusive) and weighing at least 55 kg.
• Subjects in generally good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
• Blood pressure and heart rate within normal limits.
• Electrocardiogram (ECG) with no clinically significant abnormalities recorded at screening visit (up to 28 days before dosing) and on dosing day (before drug administration).
• Negative HIV, hepatitis B and hepatitis C serology tests at screening
• No clinically significant abnormalities in complete blood count (CBC), international normalized ratio (INR), chemistry lab tests (liver and renal function) and urinalysis at screening.
• 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.
• Subjects must agree to use medically accepted form of contraception from dosing day to 12 weeks after drug administration.
• 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.

You may not qualify if:

• 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.
• Known allergy to growth hormone or any constituents or ingredients or components in the vehicle.
• 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.
• 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.
• Subjects who have received any vaccines within 4 weeks prior to study drug administration.
• Subjects who donated blood or received blood or plasma derivatives in the one month preceding signing of consent form.
• Systemic corticosteroids other than in replacement doses within the 3 months before study entry (temporary adjustment of glucocorticoids, as appropriate, is acceptable)
• Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry
• Participation in another clinical trial with drugs within one month of signing of consent form (calculated from the previous study's last dosing date).
• Subjects with an inability to communicate well with the investigators and clinic staff \[i.e., language problem (except Japanese speakers), poor mental development or impaired cerebral function\].
• 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).

Sponsors & Collaborators

• OPKO Health, Inc.: lead
• WCCT Global: collaborator

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

MOD-4023

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: April 16, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

US (1)