drugset
drugset / Trial / NCT07505043

First-in-Human Study of ISH0688: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

NCT07505043 ↗

Phase 1 Not yet recruiting 104 enrolled SUNHO（China）BioPharmaceutical CO., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

ISH0688 is a human IgG1 Fc-FGF21 fusion protein. The objectives of the planned clinical investigation will be to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending doses of ISH0688 via subcutaneous injection.

Timeline

Start
2026-03-01
Primary completion
2027-02-28
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject ISH0688 Protein / enzyme biologic 75 mg Subcutaneous
Subject ISH0688 Protein / enzyme biologic 150 mg Subcutaneous
Subject ISH0688 Protein / enzyme biologic 300 mg Subcutaneous
Subject ISH0688 Protein / enzyme biologic 600 mg Subcutaneous

Indications

hypertriglyceridemia