Mod GRF 1-29
Sermorelin, Growth Hormone Releasing Hormone (1-29), hGRF(1-29)NH2
Completed
PHASE1
INTERVENTIONAL
NCT02012556
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
Tesamorelin
Type:
DRUG
Description:
Primary Outcomes
Measure:
Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin.
TimeFrame:
Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Description:
Measure:
Peak Plasma Concentration (Cmax) of Tesamorelin.
TimeFrame:
Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Description:
Measure:
Time to Maximum Plasma Concentration (Tmax) of Tesamorelin.
TimeFrame:
Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Description:
Measure:
Apparent Elimination Half-life (T1/2 el) of Tesamorelin.
TimeFrame:
Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Description:
Measure:
Plasma Clearance (CI/F) of Tesamorelin.
TimeFrame:
Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Description:
Measure:
Apparent Volume of Distribution (Vd/F) of Tesamorelin.
TimeFrame:
Pre-dose on Days 1, 7, 12, 13, and 14, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, and 4 hours post-dose on Day 1, and at 0.05, 0.1, 0.15, 0.2, 0.25, 0.333, 0.5, 0.667, 1, 1.33, 2.5, 4, 12, and 24 hours post-dose on Day 14.
Description:
Measure:
Insulin-like Growth Factor-1 (IGF-1) Level at Day 1.
TimeFrame:
Day 1.
Description:
Measure:
Insulin-like Growth Factor-1 (IGF-1) Level at Day 7
TimeFrame:
Day 7.
Description:
Measure:
Insulin-like Growth Factor-1 (IGF-1) Level at Day 13.
TimeFrame:
Day 13.
Description:
Measure:
Insulin-like Growth Factor-1 (IGF-1) Level at Day 14.
TimeFrame:
Day 14.
Description:
Trial Information
NCT ID
NCT02012556
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Theratechnologies
Last Updated
December 15, 2025