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

ConditionsHealthy Subjects Hyperlipidemia, Hypertriglyceridemia

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSUNHO（China）BioPharmaceutical CO., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

ISH0688 for injection
Drug
75、150、300、600 mg; s.c. Q4W; Sterile powder for injection
Placebo
Drug
75、150、300、600 mg; s.c. Q4W; Sterile powder for injection

Treatment groups

104 Participants

are divided into 4 treatment groups

Group A: Single-ascending dose：Part1：ISH0688Experimental treatment 1 intervention

Group B: Single-ascending dose：Part1：placeboPlacebo comparator 1 intervention

Group C: Multiple-ascending dose：Part2：ISH0688Experimental treatment 1 intervention

Group D: Multiple-ascending dose：Part2：placeboPlacebo comparator 1 intervention

Trial outcomes