NCT05761431

A Single-dose Study of Octreotide Injection in Healthy Adult Subjects

A Single-dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Octreotide Injection in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 22 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	SYHX2008 injection	Subcutaneous administration on Day 1.
DRUG	Octreotide Acetate Microspheres for Injection injection	Intramuscular administration on Day 1.
DRUG	Sandostatin ® injection	Subcutaneous administration on Day 1.
DRUG	Placebo to SYHX2008 injection	Subcutaneous administration on Day 1.

Timeline

• Start date: 2023-03-02
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2023-03-09
• Last updated: 2023-10-10

Locations

1 site across 1 country: China