Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ambrx, Inc.
• Collaborator: Merck Serono International SA
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 18-30 years old

• GHD of childhood onset

• completed growth

• IGF-1 <=2SDS

• rhGH treatment naive

• hGH levels below cut-off

Exclusion Criteria:

• History of malignancy or intracranial tumors

• ECG abnormality

• ICH

• hepatic dysfunction

• renal impairment

• major medical conditions

• inadequate T4

• positive for HBV, HCV, or HIV

• alcohol or drug abuse