This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple intravenous ascending dose clinical study to evaluate the safety, tolerability, PK, immunogenicity, and biomarker characteristics of GenSci155 after a single or multiple intravenous injection in healthy Chinese adult trial participants.
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History of hypersensitivity to IGF-1 agents or their ingredients; or a history of allergic diathesis or a history of allergic diseases.
History or current presence of hypoglycemia, or recurrent hypoglycemic episodes.
Severe trauma or major surgical procedure within 12 months prior to screening that, in the investigator's judgment, may affect the safety of the trial participants or the interpretation of the study results, or planning to undergo any surgery during the trial period.
Blood loss or donation exceeding 400 mL within 3 months prior to screening.
Sequential
GenSci155 Injection
DrugPart 1 consists of a total of 6 dose cohorts，Part 2 consists of a total of 3 dose cohorts
Placebo
DrugPart 1 consists of a total of 6 dose cohorts，Part 2 consists of a total of 3 dose cohorts
Part1：Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures
Part2：Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures
Part1:Area under the concentration-time curve (AUC0-t, AUC0-∞,AUC0-τ)of GenSci155
Part1:maximum concentration (Cmax)
Part1:time to maximum concentration (Tmax)
Part1:terminal elimination half-life (t1/2)
Serum insulin growth factor binding protein-3 (IGFBP-3) and insulin growth factor binding protein-2 (IGFBP-2), and their changes from baseline
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This trial is not recruiting at the moment. You can still explore other options:
