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A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations

NCT06135168 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-03

No results posted yet for this study

Summary

The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.

Conditions

  • Pediatric Growth Hormone Deficiency (PGHD)

Interventions

DRUG

PEG-rhGH with new preparation

A single subcutaneous injection of PEG-rhGH with new preparation

DRUG

PEG-rhGH with present preparation

A single subcutaneous injection of PEG-rhGH with present preparation

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-11-29
Completion
2024-03-18

Countries

  • China

Study Locations

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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 NCT06135168 on ClinicalTrials.gov