A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)

NCT07016802 | Recruiting Phase 1

• 1 other identifier: GenSci134-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety; Tolerability; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events and serious adverse events

  From Day 0 to Month 3

Study Arms (3)

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®)

Interventions

GenSci134 DRUG

only one dose of GenSci134 to be given, subcutaneous , 7 dose level groups will be assigned.

GenSci134

Placebo DRUG

only one dose of GenSci134 Placebo to be given, subcutaneous , 7 dose level groups will be assigned.

GenSc134 Placebo

Recombinant Human Growth Hormone Injection (Norditropin®) DRUG

A single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days.

Recombinant Human Growth Hormone Injection (Norditropin®)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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）:
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dongyang LIU, PHD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongyang LIU, PHD

CONTACT

+86 18610966092; liudongyang@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 12, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-05

Locations

CN (1)