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A Bioequivalence Study of Two Different PEG-rhGH Preparations.

NCT06331026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-11-08

No results posted yet for this study

Summary

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Conditions

  • Pediatric Growth Hormone Deficiency (PGHD)

Interventions

DRUG

PEG-rhGH with new preparation (T)

A single subcutaneous injection of PEG-rhGH with new preparation

DRUG

PEG-rhGH with present preparation (R)

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
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2024-07-15
Completion
2024-08-28

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 NCT06331026 on ClinicalTrials.gov