Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients

A Phase 1 Study to Evaluate the Pharmacokinetics and the Pharmacodynamics of TH9507 Administered Subcutaneously Once Daily for 14 Consecutive Days in HIV Positive Patients

The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.

Main Inclusion Criteria:

• Male or female, smoker or non-smoker, ≥18 and ≤65 years of age.
• HIV-positive with CD4 cell counts >100 cells/mm3 and viral load <10 000 copies/mL.
• On stable antiretroviral therapy (ART) regimen for at least 8 weeks prior to the first study drug administration.
• Body mass index (BMI) ≥ 20.0 kg/m2.

Main Exclusion Criteria:

• Opportunistic infection or HIV-related disease within 3 months prior to study drug administration.
• History of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable Kaposi not having required treatment for the past 6 months).
• For male subjects, suspicion of prostate cancer.
• For female subjects, history of breast cancer or strong family history (first degree relative) of breast cancer.
• Known hypopituitarism, history of pituitary tumor/surgery, head irradiation or severe head trauma that had affected the somatotropic axis.
• Use of any experimental or marketed GH or GRF/GHRH products, GH secretagogues, IGF-1, or insulin-like growth factor binding protein-3 (IGFBP-3) within 6 months prior to study drug administration and throughout the study.
• Positive pregnancy test at screening.