- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01060722
MOD-4023 Study in Healthy Male Volunteers
September 27, 2019 updated by: OPKO Health, Inc.
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of a Long Acting Human Growth Hormone (hGH) Product (MOD-4023), in Healthy Volunteers
This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection at escalating doses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male volunteers aged 18-45 (inclusive) years.
- Body Mass Index (BMI) 19 to 30 kg/m2 (inclusive) and weighing at least 55 Kg.
- Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.
- 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 (blood pressure: systolic 90-140mmHg; diastolic 50-90 mmHg, heart rate 40-100 beats per minute).
- Electrocardiogram (ECG) with no clinically significant abnormalities recorded at screening visit (up to 21 days before dosing) and on dosing day (before drug administration): PR interval within 120 and 200 ms, QRS interval < 120 ms, and QTc interval ≤ 440 ms.
- Negative HIV, hepatitis B or hepatitis C serology tests at screening
- No clinically significant abnormalities in complete blood count (CBC), prothrombin time (PT, INR), activated partial thromboplastin time (aPTT), chemistry lab tests (liver and renal function) and urinalysis at screening.
- No history of alcohol or drug abuse. Negative urine 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.
Exclusion Criteria:
- 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.
- Diabetes.
- Known allergy to any drug.
- Adherence (for whatever reason) to an abnormal diet 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. Paracetamol for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
- Subjects who have received any vaccines within 4 weeks prior to study drug administration.
- Subjects who donated blood in the three months or received blood or plasma derivatives in the six months preceding study drug administration.
- Participation in another clinical trial with drugs within 3 months prior to dosing (calculated from the previous study's last dosing date).
- Subjects with an inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
- Subjects that have difficulty fasting or consuming the standard meals that will be provided.
- 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.
- Subjects who are non-cooperative or unwilling to sign a consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MOD-4023, dose level 1
|
Single subcutaneous dose of MOD-4023
Single subcutaneous dose of placebo material
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Experimental: MOD-4023, dose level 2
|
Single subcutaneous dose of MOD-4023
Single subcutaneous dose of placebo material
|
Experimental: MOD-4023, dose level 3
|
Single subcutaneous dose of MOD-4023
Single subcutaneous dose of placebo material
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
Time Frame: 30 days
|
30 days
|
Pharmacokinetics: AUC, Cmax, Tmax, T1/2
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Formation of anti-drug antibodies
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacob Atsmon, M.D., Tel-Aviv Sourasky Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
January 31, 2010
First Submitted That Met QC Criteria
February 1, 2010
First Posted (Estimate)
February 2, 2010
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 27, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CP-4-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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