First-in-Human Study of ISH0688: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics (NCT07505043) | Clinical Trial Compass
Not Yet RecruitingPhase 1
First-in-Human Study of ISH0688: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
China104 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female subjects:
✓. Male subjects with female partners of childbearing potential must agree to use adequate contraception from 30 days prior to first dosing throughout the study period and for 6 months after the last dose;
✓. Male subjects must have no plan to donate sperm from the time of informed consent signing until 6 months after study completion; female subjects must have no plan to donate eggs from the time of informed consent signing until 6 months after study completion;
✓. All subjects must be able to understand the procedures and methods of this study, be willing to strictly comply with the clinical study protocol to complete this study, and voluntarily sign the informed consent form.
✓. Male or female subjects aged 18 to 65 years (inclusive);
✓. Male body weight ≥50.0 kg, female body weight ≥45.0 kg, with body mass index (BMI) ≥19.0 and \<28.0 kg/m²;
✓. Comprehensive vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and laboratory tests (complete blood count, blood biochemistry, urinalysis, stool routine, coagulation function, thyroid function) showing no abnormalities or only minor abnormalities that are judged by the investigator to be of no clinical significance. For clinically significant abnormal laboratory findings, retesting may be performed within one week if there is a clear and reasonable justification, and the retest results will be used to determine subject eligibility.
Exclusion criteria
What they're measuring
1
Number of participants with treatment-emergent adverse events [Safety and Tolerability]
Timeframe: baseline through day 99 (part 1) or day 84 (part 2)
2
Injection site reactions assessments
Timeframe: baseline through day 99 (part 1) or day 84 (part 2)
. Undergo therapeutic lifestyle intervention during the lead-in period, maintain a stable lifestyle, and be judged by the investigator as capable of complying with the protocol to receive study treatment and complete other clinical trial procedures;
✕. Two TG tests during the lead-in period with an interval of ≥7 days, with the mean of the 2 TG values meeting 2.3 mmol/L (200 mg/dL) ≤ fasting TG \< 11.3 mmol/L (1000 mg/dL);
✕. The last TG test is within 7 days prior to the first dosing (D1).
✕. Subjects with current allergic diseases, history of allergy to therapeutic or diagnostic protein products, or allergy to two or more drugs and/or non-drug factors;
✕. Subjects with history of malignant tumors (regardless of cure status, except for basal cell carcinoma, squamous cell skin cancer, and cervical carcinoma in situ);
✕. Subjects with positive results for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or serum treponema pallidum antibody (TP-Ab) (if HBsAg positive, must also have positive HBV-DNA; if HCV-Ab positive, must also have positive HCV-RNA);
✕. Subjects with severe trauma or surgical history within 6 months prior to screening; or subjects planning to undergo surgery (including cosmetic surgery, dental surgery, and oral surgery, etc.) during the trial period;
✕. Subjects with body weight change ≥5% within 3 months prior to screening (self-reported), or use of other medications/treatments for weight reduction within 1 month prior to screening or planned during the study period;