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Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency

NCT07551804 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-26

No results posted yet for this study

Summary

This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.

Conditions

  • Adult Growth Hormone Deficiency

Interventions

DRUG

Inpegsomatropin Injection

Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week

DRUG

Placebo for Inpegsomatropin Injection

Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week

DRUG

Inpegsomatropin Injection

Inpegsomatropin Injection,initial dose 2mg/0.5ml, s.c. ,once a week

DRUG

Placebo for Inpegsomatropin Injection

Placebo for Inpegsomatropin Injection,initial dose 0.5ml, s.c. ,once a week

DRUG

Inpegsomatropin Injection

Inpegsomatropin Injection,initial dose 4mg/1ml, s.c. ,once a week

DRUG

Placebo for Inpegsomatropin Injection

Placebo for Inpegsomatropin Injection,initial dose 1.0ml, s.c. ,once a wee

Sponsors & Collaborators

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yiming Li · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2028-06-30

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 NCT07551804 on ClinicalTrials.gov