RecruitingPhase 1

Clinical Trials of IBI3035 in Healthy Subjects

China144 participantsStarted 2026-05-08

Plain-language summary

This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male adult subjects aged 18 to 45 years (including 18 and 45 years, based on the date of signing the informed consent form) of Chinese nationality;
. Body Mass Index (BMI) between 19.0 and 24.0 kg/m2 (including both values) at screening, and weight ≥ 50 kg;
. Normal glucose tolerance at screening \[3.9 mmol/L \< fasting blood glucose \< 6.1 mmol/L, and 2-hour post-glucose load blood glucose \< 7.8 mmol/L in the oral glucose tolerance test (OGTT)\]; normal insulin secretion function or abnormality without clinical significance as determined by the investigator \[confirmed by the insulin release test (IRT)\];
. Glycated hemoglobin ≤ 6.0% at screening;
. Agree to take effective contraceptive measures during the study period and within 6 months after the last dose and have no plan to donate sperm;
. Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form.

Exclusion criteria

. Known or suspected to be allergic to the investigational drug in this study;
. Have taken any drugs that affect insulin hypoglycemic effects within 28 days before screening (such as corticosteroids, diuretics, epinephrine, salbutamol, glucagon, thyroid hormones, etc.);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The area under the blood drug concentration-time curve from 0 to 168 hours

Timeframe: From 0 to 168 hours after administration

Area Under Curve Glucose Infusion Rate (AUCGIR) 0-168h

Timeframe: From 0 to 168 hours after administration

Trial details

NCT IDNCT07591519

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-30

Contact for this trial

Shanyu Xu

+86-0512-69566088 shanyu.xu@innoventbio.com

View on ClinicalTrials.gov More Healthy Person trials