Healthy SubjectsPhase 1NCT07505043
First-in-Human Study of ISH0688: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
A Phase 1 study testing ISH0688 for injection in people with Healthy Subjects and Hyperlipidemia, Hypertriglyceridemia, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Hyperlipidemia, Hypertriglyceridemia
- What is being tested?
- ISH0688 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects:
- Not of childbearing potential: Including surgical sterilization performed at least 6 weeks prior to screening (with documented records of bilateral tubal ligation, bilateral salpingectomy, hysterectomy, or bilateral oophorectomy), or postmenopausal with continuous amenorrhea for ≥12 months; or
- Of childbearing potential: Must not be pregnant or breastfeeding, and 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;
- Serum β-human chorionic gonadotropin (β-hCG) pregnancy test results must be negative at both screening and baseline visits;
- 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;
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- 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.
- Additional inclusion criteria for Part 1:
- 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;
- Fasting triglycerides (TG) <2.3 mmol/L (200 mg/dL);
- 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.
- Additional screening period inclusion criteria for Part 2:
- Male or female subjects aged 18 to 75 years (inclusive);
- Male body weight ≥50.0 kg, female body weight ≥45.0 kg, with body mass index (BMI) in the range of 19.0 to 45.0 kg/m² (inclusive);
- Lipid levels at screening or within 1 week prior to screening (at this site) meeting: fasting TG ≥2.3 mmol/L (200 mg/dL);
- Lipid-lowering medication use within 28 days prior to screening must meet the following criteria: For TG <5.7 mmol/L (500 mg/dL): no lipid-lowering medication use or receiving stable-dose lipid-lowering therapy for ≥28 days; For TG ≥5.7 mmol/L (500 mg/dL): must first receive stable-dose lipid-lowering therapy for ≥28 days; (Lipid-lowering therapy: niacin, prescription-grade fish oil, fibrates, statins, cholesterol absorption inhibitors, etc.; PCSK9 inhibitors require 6 months of stability prior to screening);
- At screening, liver fat content (LFC) assessed by MRI-PDFF ≥8% in some participants;
- Able to accept therapeutic lifestyle interventions consistent with local standards and maintain stable lifestyle throughout the study period, avoiding alcohol consumption and strenuous exercise within 48 hours prior to each visit.
- Additional double-blind treatment period inclusion criteria for Part 2:
- Meet all inclusion criteria and do not meet any exclusion criteria during the screening period;
- 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).
Who cannot join
- 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;
- Subjects with history of frequent orthostatic hypotension episodes within 6 months prior to screening;
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- Subjects with history of chronic pancreatitis or acute pancreatitis attack within 1 year prior to screening;
- Subjects with gallbladder history and symptoms (such as: common bile duct stones, multiple gallbladder stones, etc., unless cholecystectomy performed and ≥6 months since surgery);
- Subjects with alcohol consumption >14 units per week within 3 months prior to screening (1 unit of alcohol = 360 mL beer, 150 mL wine, or 45 mL spirits with 40% alcohol content), or positive alcohol breath test (at baseline);
- Drug abusers or subjects using soft drugs (e.g., marijuana) within 3 months prior to screening or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to screening, or positive drug abuse screening (morphine, ketamine, tetrahydrocannabinol acid, methamphetamine, methylenedioxymethamphetamine, cocaine);
- Subjects who have used products targeting FGF21 within 1 year prior to screening, such as BIO89-100, DR10624, etc.;
- Subjects with history of vaccination within 3 months prior to screening, or planning to receive vaccination during the trial period;
- Subjects who participated in any other clinical trial of drugs or medical devices within 3 months prior to screening (except those who did not use investigational drugs/medical devices); or subjects within 5 half-lives of a drug (if 5 half-lives of the investigational drug exceed 3 months);
- Subjects who donated blood or experienced massive blood loss (>400 mL, excluding female menstrual period) or received blood transfusion or blood products within 3 months prior to screening, or subjects planning to donate blood during the trial period;
- Subjects with severe infection within 3 months prior to screening, including but not limited to: severe pneumonia, lung abscess, meningitis, cellulitis, etc., judged by the investigator as unsuitable for participation in this trial;
- Subjects with strenuous exercise during the trial period, or significant changes in exercise or dietary habits;
- History of needle phobia or blood phobia, or inability to tolerate venipuncture;
- Subjects with dermatitis or abnormal skin conditions at or around the administration site;
- Subjects whom the investigator considers unsuitable for participation in this study for any other reason.
- Additional exclusion criteria in Part 1:
- Abnormal vital signs at screening in one or more parameters, or abnormal 12-lead electrocardiogram, or clinically significant abnormal physical examination findings;
- Clinically significant abnormal laboratory findings meeting the following criteria: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) >1.5×ULN; estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m²;
- Presence of severe, progressive, or uncontrolled diseases, including but not limited to immune system, endocrine system, hematological system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, or digestive system disorders, which in the judgment of the investigator would increase the risk to the subject by participating in this study;
- Use of any prescription drugs, over-the-counter drugs, proprietary Chinese medicines, or herbal medicines within 14 days or 5 half-lives prior to screening (whichever is longer) (excluding oral contraceptives, acetaminophen, and ibuprofen);
- Smoking more than 5 cigarettes per day on average within 3 months prior to screening;
- Excessive consumption of tea, coffee, or caffeine-containing beverages within 3 months prior to screening (more than 8 cups per day of corresponding beverages, 1 cup = 250 mL), or consumption of any caffeine-containing food or beverages (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours prior to first dosing.
- Additional exclusion criteria in Part 2:
- Known diagnosis of familial chylomicronemia syndrome (FCS) (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III); or strong suspicion of any of the above 3 conditions;
- Body weight decrease ≥5% from screening period to prior to receiving double-blind treatment;
- Clinically significant 12-lead electrocardiogram (ECG) abnormalities at screening;
- Clinically significant abnormal laboratory findings meeting the following criteria: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3.0×ULN, total bilirubin (TBIL) >2.0×ULN, creatine kinase (CK) >1.5×ULN; creatinine (Cr) >176 μmol/L and/or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m²; hemoglobin <110 g/L (males) or <100 g/L (females); platelet count (PLT) <60×10⁹/L; thyroid stimulating hormone (TSH) <lower limit of normal (LLN) or >1.5×ULN; serum amylase or lipase >2.0×ULN;
- Type 1 diabetes mellitus; or newly diagnosed Type 2 diabetes mellitus within 3 months; or poorly controlled Type 2 diabetes mellitus (HbA1c ≥9.5%); or Type 2 diabetes mellitus with severe complications; or failure to maintain stable dose of hypoglycemic agents for ≥3 months prior to screening;
- Uncontrolled or poorly controlled hypertension at screening: resting seated systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg; or failure to maintain stable dose of antihypertensive agents for ≥3 months prior to screening;
- Use (≥3 days) of other drugs significantly affecting blood lipids from 28 days prior to screening through the entire trial period (excluding lipid-lowering drugs specified in Inclusion Criterion 4), including proprietary Chinese medicines containing statin components, and other drugs and health supplements with lipid-lowering effects;
- Presence of other severe, progressive, or uncontrolled diseases in addition to T2DM, hypertension, and dyslipidemia, including but not limited to immune system, endocrine system, hematological system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, or digestive system disorders, which in the judgment of the investigator would increase the risk to the subject by participating in this study;
- Subjects who, in the investigator's assessment, require systemic corticosteroid therapy during the study period due to comorbidities, or who have received continuous or cumulative systemic corticosteroid therapy for more than 14 days within 6 months prior to screening (stable-dose inhaled or topical corticosteroids are permitted);
- Presence of contraindications to MRI examination or inability to cooperate with MRI examination;
- New York Heart Association (NYHA) Class III or IV congestive heart failure;
- Atherosclerotic cardiovascular disease within 6 months prior to screening;
- Major cardiovascular or cerebrovascular events within 6 months prior to screening;
- Severe arrhythmia within 3 months prior to screening;
- History of or current nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases significantly affecting blood lipid levels;
- History of or current hyperthyroidism or hypothyroidism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Wei Hong Jiang, 13653880139, jhwdr6@163.com
'e Cai Wang, 13837915297, 13837915297@163.com
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate ISH0688 Subcutaneous Injection
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.
- Being tested
- ISH0688 for injection, Placebo
- Medical subject headings
- Hyperlipidemias, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISH0688 for injectionDrug
75、150、300、600 mg; s.c. Q4W; Sterile powder for injection
PlaceboDrug
75、150、300、600 mg; s.c. Q4W; Sterile powder for injection
| Study group | Role | What they receive |
|---|---|---|
| Single-ascending dose：Part1：ISH0688 | Experimental | Not described Receives: Drug: ISH0688 for injection |
| Single-ascending dose：Part1：placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Multiple-ascending dose：Part2：ISH0688 | Experimental | Not described Receives: Drug: ISH0688 for injection |
| Multiple-ascending dose：Part2：placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events [Safety and Tolerability]
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Injection site reactions assessments
The injection site reaction assessment will be done by the PI/investigational staff and study subject using the criteria, which consist of rating the severity of redness, swelling, skin temperature, sensitivity and pain at the injection site
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Secondary outcomes (52)
Maximum observed serum concentration (Cmax)
Maximum observed serum concentration (Cmax)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Time to reach maximum observed serum concentration (Tmax)
Time to reach maximum observed serum concentration (Tmax)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
AUC from time 0 to the time of the dosing interval (AUC0-t)
AUC from time 0 to the time of the dosing interval (AUC0-t)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
AUC from time 0 to infinity (AUC₀-∞)
AUC from time 0 to infinity (AUC₀-∞)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Terminal elimination half-life (t1/2)
Terminal elimination half-life (t1/2)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Apparent clearance after extravascular administration (CL/F)
Apparent clearance after extravascular administration (CL/F)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F)
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Absolute Change From Baseline to Week 12 in Serum Triglyceride (TG)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in TG
Measured: baseline through day 84 (part 2)
Proportion of Participants Who Achieved TG <2.3 mmol/L (200 mg/dL) at Week 12
Measured: baseline through day 84 (part 2)
Proportion of Participants Who Achieved TG <1.7 mmol/L (150 mg/dL) at Week 12
Measured: baseline through day 84 (part 2)
Proportion of Participants With Baseline TG ≥5.7 mmol/L (500 mg/dL) Who Achieved TG <5.7 mmol/L (500 mg/dL) at Week 12
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Total Cholesterol (TC)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in TC
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in LDL-C
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in HDL-C
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Non-HDL-C
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in VLDL-C
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in ApoB
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Apolipoprotein A1 (ApoA1)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in ApoA1
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Lipoprotein(a) (Lp(a))
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Lp(a)
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Body Weight
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Body Weight
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Body Mass Index (BMI)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in BMI
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Waist Circumference
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Waist Circumference
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Fasting Plasma Glucose
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Fasting Plasma Glucose
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Glycated Hemoglobin (HbA1c)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in HbA1c
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Fasting Insulin
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Fasting Insulin
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Fasting C-Peptide
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Fasting C-Peptide
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Glucagon
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Glucagon
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Adiponectin
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Adiponectin
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in HOMA-IR
Measured: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in LFC Measured by MRI-PDFF
Measured: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
Measured: baseline through day 84 (part 2)
Incidence of Anti-Drug Antibodies (ADA)
Measured: baseline through day 99 (part 1) or day 84 (part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Mar 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by SUNHO（China）BioPharmaceutical CO., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505043
- Sponsor's protocol ID
- ISH0688-101
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate ISH0688 Subcutaneous Injection
- ClinicalTrials.gov ID
- NCT07505043
- Acronym / sponsor ID
- ISH0688-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single-ascending dose：Part1：ISH0688 | Experimental | Drug: ISH0688 for injection |
| Single-ascending dose：Part1：placebo | Placebo comparator | Drug: Placebo |
| Multiple-ascending dose：Part2：ISH0688 | Experimental | Drug: ISH0688 for injection |
| Multiple-ascending dose：Part2：placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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);
Key exclusion criteria (43 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISH0688 for injection75、150、300、600 mg; s.c. Q4W; Sterile powder for injection | Drug | Multiple-ascending dose：Part2：ISH0688, Single-ascending dose：Part1：ISH0688 |
| Placebo75、150、300、600 mg; s.c. Q4W; Sterile powder for injection | Drug | Multiple-ascending dose：Part2：placebo, Single-ascending dose：Part1：placebo |
Primary outcome
Number of participants with treatment-emergent adverse events [Safety and Tolerability]
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Injection site reactions assessments
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
The injection site reaction assessment will be done by the PI/investigational staff and study subject using the criteria, which consist of rating the severity of redness, swelling, skin temperature, sensitivity and pain at the injection site
52 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
Time to reach maximum observed serum concentration (Tmax)
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
AUC from time 0 to the time of the dosing interval (AUC0-t)
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
AUC from time 0 to infinity (AUC₀-∞)
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
Terminal elimination half-life (t1/2)
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
Apparent clearance after extravascular administration (CL/F)
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F)
Time frame: baseline through day 99 (part 1) or day 84 (part 2)
Absolute Change From Baseline to Week 12 in Serum Triglyceride (TG)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in TG
Time frame: baseline through day 84 (part 2)
Proportion of Participants Who Achieved TG <2.3 mmol/L (200 mg/dL) at Week 12
Time frame: baseline through day 84 (part 2)
Proportion of Participants Who Achieved TG <1.7 mmol/L (150 mg/dL) at Week 12
Time frame: baseline through day 84 (part 2)
Proportion of Participants With Baseline TG ≥5.7 mmol/L (500 mg/dL) Who Achieved TG <5.7 mmol/L (500 mg/dL) at Week 12
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Total Cholesterol (TC)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in TC
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in LDL-C
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in HDL-C
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Non-HDL-C
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in VLDL-C
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in ApoB
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Apolipoprotein A1 (ApoA1)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in ApoA1
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Lipoprotein(a) (Lp(a))
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Lp(a)
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Body Weight
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Body Weight
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Body Mass Index (BMI)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in BMI
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Waist Circumference
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Waist Circumference
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Fasting Plasma Glucose
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Fasting Plasma Glucose
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Glycated Hemoglobin (HbA1c)
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in HbA1c
Time frame: baseline through day 84 (part 2)
Absolute Change From Baseline to Week 12 in Fasting Insulin
Time frame: baseline through day 84 (part 2)
Percent Change From Baseline to Week 12 in Fasting Insulin
Time frame: baseline through day 84 (part 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ISH0688 for injection in people with Healthy Subjects and Hyperlipidemia, Hypertriglyceridemia, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ya Ze Jiao (15950520087, 15950520087@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events [Safety and Tolerability] (time frame: baseline through day 99 (part 1) or day 84 (part 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.