A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
GenSci134
Drugonly one dose of GenSci134 to be given, subcutaneous , 7 dose level groups will be assigned.
Placebo
Drugonly one dose of GenSci134 Placebo to be given, subcutaneous , 7 dose level groups will be assigned.
Recombinant Human Growth Hormone Injection (Norditropin®)
DrugA single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days.
Treatment groups
64 Participants
are divided into 3 treatment groupsGroup A: GenSci134Experimental treatment 1 intervention
Group B: GenSc134 PlaceboPlacebo comparator 1 intervention
Group C: Recombinant Human Growth Hormone Injection (Norditropin®)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events and serious adverse events
Time frame
From Day 0 to Month 3Sponsors and contacts
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Source ClinicalTrials.gov