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Idiopathic Short StaturePhase 1/2NCT07450053

A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS)

A Phase 1/2 study testing GenSci134 Injection and Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®) in people with Idiopathic Short Stature, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and immunogenicity of a single subcutaneous dose of GenSci134 in children with idiopathic short stature… Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Idiopathic Short Stature
What is being tested?
GenSci134 Injection and Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteChina
Study dates
6 Mar 2026to 31 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • sInformed consent of parent or legal representative of participant and child assent, as age appropriate must be obtained before any study-related activities.
  • At the time of signing the Informed consent form (ICF), the following conditions must be met:
  • Phase Ib:
  • Girls: age ≥3 and ≤11 years, breast development at Tanner stage 1, body weight ≥16 kg; Boys: age ≥3 and ≤12 years, testis volume <4 mL, body weight ≥16 kg.
  • ● Phase II: Girls: age ≥3 and ≤9 years, breast development at Tanner stage 1; Boys: age ≥3 and ≤10 years, testis volume <4 mL.
  • Diagnosis of ISS at the time of ICF signing .
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  • BMI within the range of ±2 SD of the mean BMI for age and sex at screening（Phase II only）.
  • No prior exposure to GH or IGF-1 therapy.
  • Historical measurements of body height within 6-18 months prior to screening are available(Phase II only).
  • BA-CA ≤ 1 year at screening(Phase II only).

Who cannot join

  • Presence of any suspected or confirmed condition known to affect growth, including but not limited to:
  • GHD.
  • Turner Syndrome.
  • Noonan syndrome.
  • Laron Syndrome.
  • Other genetic syndromes with short stature that are caused by chromosomal abnormalities or gene mutations, including but not limited to Prader-Willi syndrome, abnormal SHOX-1 gene analysis, or GH receptor deficiency.
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  • Born small for gestational age:
  • Growth retardation due to malnutrition.
  • Growth retardation due to hypothyroidism.
  • Short stature with any other clearly identified etiology.
  • Epiphyseal closure (Phase II only).
  • Abnormal liver function, renal function, or coagulation profile.
  • Current or prior history of any malignant disease; or a family history of malignancy.
  • Presence of impaired glucose metabolism, or HbA1c ≥ 5.7%, or a confirmed diagnosis of diabetes mellitus.
  • Clear medical history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, hematological, neurological, or metabolic disorders, or any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
  • Any clinically significant abnormality in vital signs, physical examinations, laboratory tests, 12-lead ECG, full spine anteroposterior and lateral X-ray, or B-mode ultrasound, other than those associated with the study disease, as judged by the investigator and will make the participant unsuitable for the study.
  • A positive result for any of the following serological tests during the screening period: HBsAg, Anti-HCV, Anti-HIV, or TP-Ab.
  • Known highly allergic diathesis or hypersensitivity to growth hormone products or any excipient of the investigational drug.
  • Use within a specified period prior to screening or planned use during the study of medications that may interfere with growth hormone secretion or action, or other drugs known to affect growth and development.
  • Participation in another clinical trial within 3 months prior to screening, or if the time since the last dose is less than 5 half-lives of the previous investigational drug at screening.
  • Children have been treated with systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening (Phase II only).
  • Children have been treated with inhaled budesonide or equivalent doses of inhaled glucocorticoids for more than 4 consecutive weeks within the last 12 months prior to screening (Phase II only).
  • Receipt of any blood products within 3 months prior to the first dose, poor peripheral venous access, or any medical condition that will preclude tolerance of the blood sampling procedures.
  • Administration of any vaccine within 14 days prior to the first dose or planned vaccination at any time during the study period.
  • The participant and/or the parent/legal representative is likely to be non-compliant with respect to study conduct, as judged by the investigator.
  • Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jinbo Li contact

+86 15001322766

lijinbo@genscigroup.com

China1 site

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: A Phase Ib/II Multicenter, Randomized, Open-label, Active-controlled, Single/Multiple-dose, Dose-finding, Clinical Study of GenSci134 in Children With Idiopathic Short Stature

This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and immunogenicity of a single subcutaneous dose of GenSci134 in children with idiopathic short stature (ISS).

Phase II is a multicenter, randomized, open-label, active-controlled, multiple-dose, parallel-group study to assess the efficacy and safety of multiple subcutaneous doses of GenSci134 at different levels versus Norditropin® in children with ISS. It will also evaluate PK/PD profile, immunogenicity, and biomarkers to support dose selection for Phase III.

Being tested
GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
Keywords
ISS, GenSci134

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GenSci134 InjectionDrug

    Also called GenSci134

    only one dose of GenSci134 to be given, subcutaneous , 6 dose levels will be assigned.

  • Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)Drug

    Also called Norditropin®

    multiple doses of Norditropin® FlexPro® quaque die (QD) for 28 consecutive days by subcutaneous injections.

Study groups in NCT07450053
Study groupRoleWhat they receive
Dose Level 1~ Dose Level 6Experimentaldose level 1、dose level 2、dose level 3、dose level 4、 dose level 5、dose level 6
Receives: Drug: GenSci134 Injection
Recombinant Human Growth Hormone Injection (Norditropin®)Active comparatorActive control group
Receives: Drug: Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: Incidence of Treatment Emergent Adverse Events （TEAEs）

    Measured: From Day 1 to Day 35

  2. Phase II: Annualized height velocity (AHV) at Week 24 of treatment

    Measured: 24 weeks

Secondary outcomes (13)

  1. Phase Ib: Areas under the drug concentration-time curve (AUC0-t, AUC0-∞) of GenSci134

    Measured: From Day 1 to Day 29

  2. Phase Ib: Time to maximum concentration (Tmax) of GenSci134

    Measured: From Day 1 to Day 29

  3. Phase Ib: Maximum concentration (Cmax) of GenSci134

    Measured: From Day 1 to Day 29

  4. Phase Ib: Half-life (t1/2) of GenSci134

    Measured: From Day 1 to Day 29

  5. Phase Ib: Serum level of IGF-1and IGFBP-3 and their changes from baseline.

    Measured: rom Day 1 to Day 29

  6. Phase Ib: Incidence and timing of positive anti-drug antibody (ADA) and/or neutralizing antibody (NAb) (if applicable)

    Measured: From Day 1 to Day 29

  7. Phase II: Change from baseline in HT SDS at each visit

    Measured: From baseline to Week 24 of the treatment period

  8. Phase II: Change from baseline in AHV at each visit

    Measured: From baseline to Week 24 of the treatment period

  9. Phase II: Change from baseline in BA/CA at each visit

    Measured: From baseline to Week 24 of the treatment period

  10. Phase II: Incidence of TEAEs

    Measured: From the first dose to the end of the trial

  11. Phase II: Serum concentration of GenSci134.

    Measured: From baseline to Week 24 of the treatment period

  12. Phase II: Serum level of IGF-1and IGFBP-3 and their changes from baseline.

    Measured: From baseline to Week 24 of the treatment period

  13. Phase II: Incidence and timing of positive ADA and/or NAb (if applicable).

    Measured: From baseline to Week 24 of the extension period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study start6 Mar 2026 (estimated)
  3. Primary completion18 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450053
Sponsor's protocol ID
GenSci134-203
Status last verified
Feb 2026
First submitted
12 Feb 2026
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GenSci134 Injection and Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®) in people with Idiopathic Short Stature, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinbo Li (+86 15001322766, lijinbo@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Incidence of Treatment Emergent Adverse Events （TEAEs） (time frame: From Day 1 to Day 35). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07450053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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