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

NCT07505043 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Healthy Subjects
  • Hyperlipidemia, Hypertriglyceridemia

Interventions

DRUG

ISH0688 for injection

75、150、300、600 mg; s.c. Q4W; Sterile powder for injection

DRUG

Placebo

75、150、300、600 mg; s.c. Q4W; Sterile powder for injection

Sponsors & Collaborators

  • SUNHO（China）BioPharmaceutical CO., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07505043 on ClinicalTrials.gov