clinical trial · NCT05761431
A Single-dose Study of Octreotide Injection in Healthy Adult Subjects
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·phase1·completed·n = 56
AcromegalySYHX2008 injectionOctreotide Acetate Microspheres for Injection injectionSandostatin ® injectionPlacebo to SYHX2008 injection
brief summary
This is a single-centre, single-dose, dose-escalation, placebo and positive drug-controlled Phase I clinical study in healthy Chinese subjects to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of octreotide injection in healthy Chinese subjects.
started
Mar 2, 2023
primary completion
Jun 28, 2023
completion
Jun 28, 2023
last updated
Oct 10, 2023
detailed description
This single centre study will be comprised of 6 cohorts. The single ascending dose part is comprises of 4 cohorts（5 mg, 10 mg, 20 mg, 30 mg).
The other 2 cohorts are octreotide long-acting release ( Sandostatin LAR® ) 20 mg and Sandostatin® 0.1 mg.
official title
A Single-dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Octreotide Injection in Healthy Adult Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol