MOD-4023 Study in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060722
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : April 7, 2015
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Opko Biologics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: MOD-4023 (long lasting hGH) Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: MOD-4023, dose level 1 Drug: MOD-4023 (long lasting hGH)
Single subcutaneous dose of MOD-4023

Drug: Placebo
Single subcutaneous dose of placebo material

Experimental: MOD-4023, dose level 2 Drug: MOD-4023 (long lasting hGH)
Single subcutaneous dose of MOD-4023

Drug: Placebo
Single subcutaneous dose of placebo material

Experimental: MOD-4023, dose level 3 Drug: MOD-4023 (long lasting hGH)
Single subcutaneous dose of MOD-4023

Drug: Placebo
Single subcutaneous dose of placebo material

Primary Outcome Measures :
  1. Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction) [ Time Frame: 30 days ]
  2. Pharmacokinetics: AUC, Cmax, Tmax, T1/2 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Formation of anti-drug antibodies [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01060722

Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Opko Biologics
Tel-Aviv Sourasky Medical Center
Principal Investigator: Jacob Atsmon, M.D. Tel-Aviv Sourasky Medical Center

Responsible Party: Opko Biologics Identifier: NCT01060722     History of Changes
Other Study ID Numbers: CP-4-001
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Opko Biologics:
Healthy Male Volunteers