Growth Hormone DeficiencyPhase 1NCT02418767
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
A Phase 1 study testing MOD-4023 in people with Growth Hormone Deficiency, run by OPKO Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- MOD-4023
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- MOD-4023, Placebo
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOD-4023Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo Receives: 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 Receives: 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 Receives: Drug: MOD-4023; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
IGF-1 and IGFBP-3 serum levels (T1/2, AUC, Cmax, Tmax)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418767
- Sponsor's protocol ID
- CP-4-007
- Status last verified
- Sep 2019
- First submitted
- 8 Jan 2015
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02418767
- Acronym / sponsor ID
- CP-4-007
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: MOD-4023, Drug: Placebo7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| Mid dose | Experimental | Drug: MOD-4023, Drug: Placebo7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| High dose | Experimental | Drug: MOD-4023, Drug: Placebo7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOD-4023 | Drug | High dose, Low dose, Mid dose |
| Placebo | Drug | High dose, Low dose, Mid dose |
Primary outcome
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
Time frame: 30 days
To assess the safety, tolerability and immunogenicity of MOD-4023 in healthy Caucasian and Japanese subjects after single subcutaneous (SC) dose.
Pharmacokinetics (PK) profile of MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose
Time frame: 7 days
MOD-4023 serum levels (T1/2, Area-Under-the-Curve, Cmax, Tmax)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MOD-4023 in people with Growth Hormone Deficiency, run by OPKO Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.