None listed
Conditions
Interventions
Intervention1: Long-acting Recombinant Growth Hormone (ALT-P1), Manufactured By: BINEX Co., Ltd. Formulation strength: 30 mg/vial of ALT-P1.
Dose:0.2- 0.8 mg/kg weekly administration.
: The subjects
Sponsors
Alteogen Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and non pregnant female human subjects, age in the range of 18 ââ?¬â?? 45 years both inclusive. 2.Body Mass Index between 18.5-30.0 Kg / m2 extremes included. 3.Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature). 4.Subjects with clinically acceptable findings as determined by haematology, biochemistry including lipid profile test, urinalysis, 12-lead ECG and chest X-ray (if required). 5.Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until after the last blood sample collection in cohort of the study and adherence to food, fluid and posture restrictions. 6.No history of significant alcoholism. 7.No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs (Appendix H) for the last 06 months. 8.Non-smokers, ex-smokers and moderate smokers will be included. ââ?¬Å?Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who completely stopped smoking for at least 3 months.ââ?¬? 9.At least 25 % fall in IGF-1 levels on day -2 from the baseline (day -17). 10. Agree to use: ââ?¬Â¢A condom, if the subjects are engaged in sexual activity with a pregnant woman ââ?¬Â¢A condom along with another medically acceptable contraceptive method, if the subjects engage in sexual activity with a woman of childbearing potential. Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide).
Exclusion criteria
Exclusion criteria: 1.Known history of hypersensitivity to daily growth hormone (NorditropinÃ?®) or Octreotide injection or related drugs. 2.Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day. 3.Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IMP. 4.Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, bloodââ?¬â??forming organs etc. 5.History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases. 6.Participation in a clinical drug study or bioequivalence study 180 days prior to dosing of the present study. 7.History of malignancy or other serious diseases. 8.Blood donation 180 days prior to dosing of the present study. 9.Subjects with positive HIV tests, HBsAg, Hepatitis-C or Anti HBc IgM tests. 10.Found positive in breath alcohol test. 11.Found positive in urine test for drug abuse. 12.Any contraindication to blood sampling. 13.Female subjects found positive serum (Ã?²) Beta- hCG (Human Chorionic Gonadotropin) test. 14.Lactating women (currently breast feeding). 15.Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable. 16.Use of hormonal contraceptives either oral or implants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetics and pharmacodynamics of single and repeated four-level doses of Test Products (long-acting recombinant growth hormone, ALT-P1) with one week daily subcutaneous doses of Reference Product (R) (NorditropinÃ?®) when given in 16 Ã?¼g/kg/day or 0.048 IU/kg/day dose in healthy subjects.Timepoint: Pk: ALT-P1: 1st & 6th doses: -00.50, 2, 4, 8, 12, 18, 24, 36, 48, 72, 96, 120, 144 & 168 hrs post-dose. 2nd to 6th doses: 48hrs post-dose. Norditropin: 1st & 7th doses:-00.50, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose. 2nd to 6th dose: 400 hrs post-dose. PD: ALT-P1: 1st dose:-00.50, 00, 24, 48, 72, 96, 120, 144, 168, 240, 336, 408, 576, 672, 744, 840, 912 and 1008 hrs post dose. Norditropin: 1st dose:-00.50, 00, 12, 16, 24, 48, 72, 96, 168 hrs post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety, tolerability and local tolerance of four-level doses of Test Products (long-acting recombinant growth hormone, ALT-P1) with one week daily subcutaneous doses of Reference Product (R) (NorditropinÃ?®).Timepoint: Injection site reactions (pain and appearance) for Octreotide injection (Sandostatin LARÃ?®), ALT-P1 and NorditropinÃ?®.For Octreotide injection (Sandostatin LARÃ?®): 04 and24 hrs post dose. For ALT-P1 : 1st dose: 00.083, 00.50,1,2,3,4,6,8,10,12,16,24,48,72&96 hrs post dose. Subsequent doses: Pre-dose, 4,48 hrs Post dose. For NorditropinÃ?®: 1st dose: 00.083, 00.50, 1, 2, 3, 4, 6, 8, 10, 12, 16 hrs post dose and prior to subsequent all daily dosing up to Day 7. | — |
Countries
India
Contacts
Public ContactSheetal Kadam
Accutest Research Laboratories (I) Pvt. Ltd
Outcome results
None listed