r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Growth Failure

Growth Hormone Deficiency

Treatments

Biological: r-hGH liquid (Saizen)

Biological: r-hGH freeze-dried

Study type

Interventional

Funder types

Industry

Identifiers

NCT01034735

28798

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Main inclusion criteria:

Male and female aged 18 to 45 years, inclusive; who are able to read, to write and to fully understand German language
Had given written Informed Consent
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)
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
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
Were able to communicate well with the Investigator and willing to comply with the requirements of the entire trial
Were willing to undergo pituitary down-regulation by intravenous infusion with somatostatin for 25 hours

If female:
Had a negative serum pregnancy test within three weeks prior to trial start and a negative urine pregnancy test at the day before dosing
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 exclusion criteria:

Any surgical or medical condition, including findings in the medical history or in the pre trial assessments, that in the opinion of the Investigator, constituted a risk or a contraindication for the participation of the subject in the trial or that could have interfered with the trial objectives, conduct or evaluation
Had any clinically significant abnormal laboratory test results in the pre-trial safety laboratory tests or any clinically abnormal findings on the 12 leads resting electrocardiogram (ECG) that in the opinion of the Investigator may have increased the safety risk to the subject
Had positive results for drugs of abuse or alcohol test
Had positive results from serology examination for Hepatitis B surface antigen (HBsAg) (not due to vaccination), Hepatitis B core antibody (HBcAb) (if positive, was to be verified by test for anti-Hbc-IgM), Hepatitis C Virus (anti-HCV) and Human Immunodeficiency Virus (anti-HIV 1 and 2) at screening
History or presence of hypertension or other significant cardiovascular abnormalities
History or presence of cholelithiasis
Significant history or clinical evidence of auto-immune, gastrointestinal, haematological, hematopoietic, hepatic, neurological, pancreatic or renal disease
History or presence of diabetes
History or presence of tumors of the pituitary gland or hypothalamus
Definite or suspected personal history or family history of adverse drug reaction or hypersensitivity to drugs with a similar chemical structure to somatropin or somatostatin or its excipients, use of any chronic medication