Health TrialsbyHealthPanel

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

ConditionAdult Growth Hormone Deficiency
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorXiamen Amoytop Biotech Co., Ltd.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male study participants aged ≥ 18 years and < 80 years at the time of signing the informed consent form (ICF);

No systemic treatment with growth hormone or growth hormone secretagogues within 6 months prior to entering the screening period;

For patients with any other pituitary hormone deficiency who are on hormone replacement therapy (HRT) at screening, HRT must have been stable for at least 3 months;

Study participants must agree to use reliable contraceptive measures with their spouses from - Study participants fully understand the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in the study, and have signed the informed consent form.

Disqualifiers

Individuals with known or suspected hypersensitivity to the investigational product or its excipients;

Patients with severe malnutrition as judged by the investigator, or with a BMI < 18.5 kg/m² at screening;

Patients with active malignancy or a history of malignancy; or with thyroid nodules classified as TI-RADS grade ≥ 4a on thyroid ultrasound; or with high-risk or suspected malignant nodules detected on chest CT; or with clinically significant abnormal tumor markers at screening;

Surgical resection of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Inpegsomatropin Injection

    Drug

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

  • Placebo for Inpegsomatropin Injection

    Drug

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

  • Inpegsomatropin Injection

    Drug

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

  • Placebo for Inpegsomatropin Injection

    Drug

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

  • Inpegsomatropin Injection

    Drug

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

  • Placebo for Inpegsomatropin Injection

    Drug

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

Treatment groups

36 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: A group: Inpegsomatropin Injection low doseExperimental treatment 1 intervention
Group B: A group:Placebo for Inpegsomatropin Injection low dosePlacebo comparator 1 intervention
Group C: B group: Inpegsomatropin Injection middle doseExperimental treatment 1 intervention
Group D: B group:Placebo for Inpegsomatropin Injection middle dosePlacebo comparator 1 intervention
Group E: C group: Experimental:telpegfilgrastim Injection highExperimental treatment 1 intervention
Group F: C group:Placebo for Inpegsomatropin Injection high dosePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Event

Time frame
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
2

Serious Adverse Event

Time frame
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
3

Number of Participants with Abnormal Laboratory Parameters Findings

Time frame
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
4

HR (bpm)

Time frame
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiamen Amoytop Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now