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MOD-4023 Study in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Prolor Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01060722
First received: January 31, 2010
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Healthy
Drug: MOD-4023 (long lasting hGH)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Prolor Biotech, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: AUC, Cmax, Tmax, T1/2 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Formation of anti-drug antibodies [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060722

Locations
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Prolor Biotech, Inc.
Investigators
Principal Investigator: Jacob Atsmon, M.D. Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Jacob Atsmon, M.D. (Principle Investigator), Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01060722     History of Changes
Other Study ID Numbers: CP-4-001
Study First Received: January 31, 2010
Last Updated: February 10, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Prolor Biotech, Inc.:
Healthy Male Volunteers

ClinicalTrials.gov processed this record on November 20, 2014