SafetyPhase 1NCT07016802
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)
A Phase 1 study testing GenSci134 and Recombinant Human Growth Hormone Injection (Norditropin®) in people with Safety and Tolerability, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of GenSc134 is in AGHD patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, Adult Growth Hormone Deficiency
- What is being tested?
- GenSci134 and Recombinant Human Growth Hormone Injection (Norditropin®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2025to 25 Nov 2026
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The first part in Healthy adult volunteers:
- Healthy adult male subjects（Phase Ia），or Healthy adult subjects（Phase Ib） aged 18-45 years (inclusive of boundary values);
- Body Mass Index (BMI): 19.0-24.0 kg/m² (inclusive of boundary values);
- Good health status;
- Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions.
- The second part in AGHD patients（Phase Ic）:
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- Be able to understand and be willing to sign the written ICF (before any study procedure is performed).
- Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other specified study procedures.
- Aged from 20 to 70 years old (inclusive), at the time of signing the ICF.
- Body mass index (BMI): 18.0-32.0 kg/m² ((inclusive of boundary values).
- Meeting any of the following diagnostic criteria for growth hormone deficiency:
- Adult-onset: Participants with GHD due to hypothalamo-pituitary disorder or relevant treatments (surgery, radiotherapy) or other reasons (infection, traumatic craniocerebral injury, etc.); the participant has no relapse or residual disease is stable for more than 1 year after surgery for pituitary adenoma, surgery for craniopharyngioma or other pituitary gland operation.
- Childhood-onset: Participants with childhood idiopathic, acquired, congenital GHD or childhood GHD for other reasons.
- Confirmed diagnosis of AGHD (meeting at least one of the following criteria):
- Insulin tolerance test: peak GH cut-off point ≤ 5 μg/L.
- Glucagon challenge test:
- a) Participants with BMI < 25 kg/m² or high clinical suspicion [≥ 3 pituitary hormone deficiencies (PHDs)] with BMI 25-30 kg/m², peak GH ≤ 3 μg/L.
- b) Participants with BMI > 30 kg/m² or low clinical suspicion (≤ 2 PHDs) with BMI 25-30 kg/m², peak GH ≤ 1 μg/L.
- ≥ 3 PHDs and IGF-1 SDS < -2.0 at screening.
- Participants who have not previously received human growth hormone (hGH) therapy or are in the washout period of previous hGH therapy.
Who cannot join
- The first part in Healthy adult volunteers:
- Subjects with significant medical history or clinical manifestations determined by the investigator;
- History of hypersensitivity, intolerance, or allergy to any drug, compound, food, or other substances, or known allergy to any excipients of the study drug;
- History of neurological or psychiatric disorders, or subjects with impaired consciousness or cognitive dysfunction;
- Subjects with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant;
- Subjects with immunodeficiency or immunosuppressive diseases at screening;
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- Subjects who have undergone major surgery within 12 months prior to screening;
- Subjects with a history of neoplastic diseases;
- Subjects who have participated in any other clinical trial of drugs or medical devices and have used the investigational medicinal product within 28 days or 5 half-lives (whichever is longer) before dosing.
- The second part in AGHD patients（Phase Ic）:
- Known or suspected hypersensitivity to the investigational medical product and/or any of its excipients.
- Female participants who are pregnant, breast-feeding or intend to become pregnant or are of childbearing potential but not using an effective contraceptive method.
- Male participants with fertility potential or their partners who do not use an effective contraceptive method.
- Clinically significant hepatic disease.
- Clinically significant chronic renal insufficiency.
- Cardiac failure.
- Use of any investigational product within 30 days prior to screening or participated in another trial within 30 days prior to dosing.
- Use of systemic corticosteroids at non-alternative doses within 90 days prior to dosing.
- Any disorder or treatment which, in the opinion of the investigator, possibly jeopardizes participant's safety or affects his/her compliance with the protocol.
- History of diabetes mellitus.
- History of malignancy or ongoing malignancy.
- Active Cushing's syndrome within 24 months prior to dosing.
- Acute severe diseases resulting in weight loss within 180 days prior to dosing.
- Use of weight-reducing drugs known to affect body weight significantly within 12 months prior to dosing.
- Presence of a mental or language disorder that impairs the ability to understand or cooperate with the study, unwillingness to participate, or any other condition that, in the opinion of the investigator or treating physician, renders the participant unsuitable for the trial.
- Anticipated change in lifestyle during the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
Dongyang LIU, 18610966092, liudongyang@vip.sina.com
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo and Active-controlled Study of Single and Multiple Ascending Doses of GenSci134 Injection in Healthy Adults, and a Single Ascending Dose in Patients With Adult Growth Hormone Deficiency
To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of GenSc134 is in AGHD patients.
Read the detailed description
This study consists of two parts: the first part is the study in healthy volunteers, and the second part is the study in AGHD patients.
The first part consists of two phases. Phase Ia is a single-ascending dose study in healthy male volunteers, and Phase Ib is a multiple-ascending dose study healthy male or female volunteers.
The second part is Phase Ic，which is a a single-ascending dose study in AGHD patients.
Phase Ia：GenSci134 was tested in 7 predetermined single dose groups with placebo and positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 64 healthy adult male volunteers.
Phase Ib：GenSci134 was tested in 3 predetermined multiple dose groups with placebo, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity in 36 healthy adult volunteers.
Phase Ic :GenSci134 was tested in 2 predetermined dose groups with positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 16 AGHD patients.
- Conditions
- Safety, Tolerability, Adult Growth Hormone Deficiency
- Being tested
- GenSci134, Placebo, Recombinant Human Growth Hormone Injection (Norditropin®)
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci134Drug
only one dose of GenSci134 to be given, subcutaneous , 7 dose level groups will be assigned.
PlaceboDrug
only one dose of GenSci134 Placebo to be given, subcutaneous , 7 dose level groups will be assigned.
Recombinant Human Growth Hormone Injection (Norditropin®)Drug
A single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| GenSci134 | Experimental | Not described Receives: Drug: GenSci134 |
| GenSc134 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Recombinant Human Growth Hormone Injection (Norditropin®) | Active comparator | Not described Receives: Drug: Recombinant Human Growth Hormone Injection (Norditropin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events and serious adverse events
Measured: From Day 0 to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start9 Jun 2025
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongyang LIU, PHD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016802
- Sponsor's protocol ID
- GenSci134-101
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo and Active-controlled Study of Single and Multiple Ascending Doses of GenSci134 Injection in Healthy Adults, and a Single Ascending Dose in Patients With Adult Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT07016802
- Acronym / sponsor ID
- GenSci134-101
- Conditions
- Safety, Tolerability, Adult Growth Hormone Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of GenSc134 is in AGHD patients.
Detailed description
This study consists of two parts: the first part is the study in healthy volunteers, and the second part is the study in AGHD patients.
The first part consists of two phases. Phase Ia is a single-ascending dose study in healthy male volunteers, and Phase Ib is a multiple-ascending dose study healthy male or female volunteers.
The second part is Phase Ic，which is a a single-ascending dose study in AGHD patients.
Phase Ia：GenSci134 was tested in 7 predetermined single dose groups with placebo and positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 64 healthy adult male volunteers.
Phase Ib：GenSci134 was tested in 3 predetermined multiple dose groups with placebo, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity in 36 healthy adult volunteers.
Phase Ic :GenSci134 was tested in 2 predetermined dose groups with positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 16 AGHD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GenSci134 | Experimental | Drug: GenSci134 |
| GenSc134 Placebo | Placebo comparator | Drug: Placebo |
| Recombinant Human Growth Hormone Injection (Norditropin®) | Active comparator | Drug: Recombinant Human Growth Hormone Injection (Norditropin®) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Healthy adult male subjects（Phase Ia），or Healthy adult subjects（Phase Ib） aged 18-45 years (inclusive of boundary values);
- Body Mass Index (BMI): 19.0-24.0 kg/m² (inclusive of boundary values);
- Good health status;
- Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions.
- Be able to understand and be willing to sign the written ICF (before any study procedure is performed).
Key exclusion criteria (26 listed)
- Subjects with significant medical history or clinical manifestations determined by the investigator;
- History of hypersensitivity, intolerance, or allergy to any drug, compound, food, or other substances, or known allergy to any excipients of the study drug;
- History of neurological or psychiatric disorders, or subjects with impaired consciousness or cognitive dysfunction;
- Subjects with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant;
- Subjects with immunodeficiency or immunosuppressive diseases at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenSci134only one dose of GenSci134 to be given, subcutaneous , 7 dose level groups will be assigned. | Drug | GenSci134 |
| Placeboonly one dose of GenSci134 Placebo to be given, subcutaneous , 7 dose level groups will be assigned. | Drug | GenSc134 Placebo |
| Recombinant Human Growth Hormone Injection (Norditropin®)A single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days. | Drug | Recombinant Human Growth Hormone Injection (Norditropin®) |
Primary outcome
Incidence and severity of adverse events and serious adverse events
Time frame: From Day 0 to Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dongyang LIU, PHD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GenSci134 and Recombinant Human Growth Hormone Injection (Norditropin®) in people with Safety and Tolerability, 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 20 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: looking for participants now, as of the sponsor's last update on 14 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Dongyang LIU, PHD (+86 18610966092, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events and serious adverse events (time frame: From Day 0 to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.