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

NCT05761431 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yang NA Lin, PhD · Beijing Anzhen Hospital

  • Shan NA Jing, PhD · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-02
Primary Completion
2023-06-28
Completion
2023-06-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761431 on ClinicalTrials.gov