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

Recruiting Phase 2 Interventional Study
Adult Growth Hormone Deficiency
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Xiamen Amoytop Biotech Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male study participants aged ≥ 18 years and \< 80 years at the time of signing the informed consent form (ICF); * Study participants meeting the criteria for adult growth hormone deficiency (AGHD): Patients with a peak GH level \< 5 μg/L measured by insulin tolerance test (IT…
Contacts

Yiming Li, Ph.D

13501936597

yimingli@fudan.edu.cn

CONTACT