BridgeMD
New treatment option for Safety
Official title A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)
ClinicalTrials.gov ID: NCT07016802
What this study is testing
What is GenSci134?
GenSci134 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for safety.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- The first part in Healthy adult volunteers:
- Healthy adult male people（Phase Ia），or Healthy adult people（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...
You likely can't join if
- The first part in Healthy adult volunteers:
- people 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...
- History of neurological or psychiatric disorders, or people with impaired consciousness or cognitive dysfunction;
- people with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and...
- people with immunodeficiency or immunosuppressive diseases at screening;
See the full eligibility criteria
- The first part in Healthy adult volunteers:
- Healthy adult male people（Phase Ia），or Healthy adult people（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...
- 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.
- The first part in Healthy adult volunteers:
- people 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 people with impaired consciousness or cognitive dysfunction;
- people with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant;
- people with immunodeficiency or immunosuppressive diseases at screening;
- people who have undergone major surgery within 12 months prior to screening;
- people with a history of neoplastic diseases;
- people 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...
- 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...
- Anticipated change in lifestyle during the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.