Growth Failure, Growth Hormone Deficiency
Conditions
Keywords
Saizen®, bioequivalence, recombinant human, Growth Hormone, treatment of growth failure in children, growth hormone deficiency in adults
Brief summary
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference. Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.
Interventions
BIOLOGICALr-hGH liquid (Saizen)
Treatment Arm A: r-hGH liquid multidose formulation 5.83 mg/mL, needle injection (0.686 mL)
BIOLOGICALr-hGH freeze-dried
Treatment Arm C: r-hGH 8 mg (8.8 mg/1.51 ml) freeze-dried formulation ( reconstituted in metacresol 0.3% w/v) needle injection (0.686 mL)
Sponsors
EMD Serono
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Main inclusion criteria: 1. Male and female aged 18 to 45 years, inclusive; who are able to read, to write and to fully understand German language 2. Had given written Informed Consent 3. Had a body weight greater than 55 kg and a body mass index (BMI) of \>20 and \< or = 30 kg/m2 (BMI = weight (kg)/height (m)2) 4. Had vital signs in the following normal range: Ear body temperature: 35.0 - 38.0°C Blood pressure (BP) - after at least 3 minutes of rest, measured in the supine position: systolic blood pressure: 90 - 145 mmHg diastolic blood pressure : 50 - 95 mmHg Pulse rate (PR): after at least 3 minutes of rest, measured in the supine position: 40 90 bpm 5. Smoked less than 10 cigarettes per day, consented to smoke less than 5 cigarettes per day during the trial period and were able to refrain from smoking during the confinement period 6. Were able to communicate well with the Investigator and willing to comply with the requirements of the entire trial 7. Were willing to undergo pituitary down-regulation by intravenous infusion with somatostatin for 25 hours If female: 8. Had a negative serum pregnancy test within three weeks prior to trial start and a negative urine pregnancy test at the day before dosing 9. Were pre-menopausal and using an adequate method of non-hormonal contraception (2 barrier methods, or one barrier method with spermicide, or non-hormonal intrauterine device), sexual abstinence or females with vasectomised partners during the entire trial
Exclusion criteria
Main
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints were the pharmacokinetic (PK) parameters of r-hGH: the area under the serum concentration-time curve from time zero to last detectable serum concentration (AUC0 t) and the maximum observed serum concentration (Cmax). | 24 hours post r hGH dose |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints included further PK parameters. | 15 +/-3 days post last r hGH dose |
| Safety and tolerability were evaluated by adverse events (AEs), medical history, physical examination, vital signs, local tolerability, visual analog scale (VAS), ECG recordings, glycemia measurements and laboratory tests. | 15 +/-3 days post last r hGH dose |
Countries
Germany
Outcome results
None listed