Trials / Not Yet Recruiting
Not Yet RecruitingNCT07505043
First-in-Human Study of ISH0688: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate ISH0688 Subcutaneous Injection
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-02-28
- Completion
- 2027-02-28
- First posted
- 2026-04-01
- Last updated
- 2026-04-01
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07505043. Inclusion in this directory is not an endorsement.