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New injection Y-3 put to the test: will it clash with common drugs?

NCT ID NCT07068841

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 trial in 24 healthy adults checked whether an experimental injection called Y-3 changes how the body handles three common drugs: repaglinide (for diabetes), warfarin (a blood thinner), and omeprazole (for heartburn). Participants took these drugs alone and then again while receiving Y-3. The goal was to see if Y-3 causes drug interactions, which would affect dosing instructions. This is a safety and drug-level study, not a treatment trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Y-3 for injection
What this could lead to
If successful, this study could help doctors understand whether Y-3 injection can be safely used with common medications like repaglinide, warfarin, and omeprazole.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It only looks at drug levels in the blood, not actual treatment outcomes. Results may not apply to people with medical conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

May 2025

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\) Participants fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as participants, and sign the informed consent form before the start of any study procedures; 2) Healthy male or female participants aged 18 \~ 50 years old (including 18 and 50 years old); 3) Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index \[BMI = weight (kg)/ height (m)2\]: 19.0-26.0 kg/m2, including 19.0 and 26.0 kg/m2; 4) The results of vital signs, physical examination, 12-lead electrocardiogram examination, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), chest X-ray and laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, four items before blood transfusion, fecal occult blood examination) are normal or judged by the investigator to be abnormal of no clinical significance; 5) Participants (including male participants) have no fertility plan and voluntarily take effective contraceptive measures (contraceptive measures other than contraceptive drugs during the trial) within 3 months after signing the informed consent form to dosing, and have no sperm donation and egg donation plans; 6) Able to communicate well with the investigator, and understand and comply with the requirements of the trial. Exclusion Criteria: * 1\) People with allergies: allergies to medicines, food, pollen, etc., or those who have a history of allergy to repaglinide tablets, warfarin sodium tablets, omeprazole enteric-coated capsules, Y-3 for injection or any of components of above investigational products; 2) Those who have diseases or medical history that may affect drug absorption, distribution, metabolism, excretion or interpretation of safety data, or diseases or medical history that can reduce compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, tumor, immunologic, psychiatric or cardiovascular and cerebrovascular diseases (especially liver and kidney insufficiency, diabetes, hypoglycemia, bleeding tendency or cachexia, malignant hypertension, thrombocytopenia); 3) Those who have undergone surgery within 6 months before the first use of the investigational products, or have undergone surgery that will affect the absorption, distribution, metabolism, and excretion of the investigational products, or plan to undergo surgery during the trial; 4) Those who have a history of fainting needle and blood sickness, cannot tolerate venipuncture blood collection, cannot tolerate intravenous administration and/or have difficulty in blood collection; 5) Those who cannot comply with the uniform diet (such as special dietary requirements, intolerance to standard meals, etc.); 6) For patients with creatinine clearance \<80 mL/min, creatinine clearance (mL/min) = \[(140-age) × body weight (kg)\]/\[72×Scr(mg/dl)\] or creatinine clearance (mL/min) = \[(140-age) × body weight(kg)\]/\[0.818×Scr(μmol/L)\], female study participants were × 0.85 according to the calculated results; 7) Those who have participated in or are participating in other clinical trials within 3 months before the first use of the investigational products (drug clinical trial is defined as the use of clinical investigational products), or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial, or those who do not come to participate in clinical trials in person; 8) Those who have donated blood (including component blood) or had heavy bleeding (greater than 400 ml, except for blood loss during normal menstrual period in women) within 3 months before the first use of the investigational products, or received blood transfusion or used blood products, or plan to donate blood or blood components during the study or within 1 month after the end of the study; 9) Those who have had significant changes in diet or exercise habits within 3 months before the first use of the investigational products; 10) Those who have an average daily smoking volume of more than 5 cigarettes within 3 months before the first use of the investigational products, or cannot stop using any tobacco products (including any smoking cessation products containing nicotine) within 48 hours before the first use of the investigational products and during the trial; 11) Those who have a history of drug abuse or drug use within 6 months before the first use of the investigational products, or who are positive for drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinolic acid, dimethylenedioxyamphetamine); 12) Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) per week within 3 months before the first use of the investigational products, or who cannot abstain from alcohol or stop using any diet containing alcohol within 48 hours before the first use of the investigational products and during the trial, or have a positive alcohol breath test result (greater than 0.0 mg/100 mL); 13) Those who consume excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before the first use of the investigational products, or cannot stop using caffeine-rich foods or beverages (such as chocolate, coffee, tea, cola, etc.) within 48 hours before the first use of the investigational products and during the trial; 14) Those who have used any drug that can change the activity of liver drug enzymes within 1 month before the first use of the investigational products; 15) Those who have been vaccinated within 1 month before the first use of the investigational products, or plan to receive any vaccine during the trial or within one week after the end of the trial; 16) Those who have used any prescription medicines, over-the-counter medicines, Chinese herbal medicines, health products and functional vitamins within 14 days before the first use of the investigational products; 17) Those who have one or more positive test results for hepatitis B surface antigen, hepatitis C virus antibody, HIV1/2 antigen/antibody and treponema pallidum antibody; 18) Females of childbearing potential who have had unprotected sex within 14 days prior to the first use of investigational products, or females who are pregnant or lactating, or who have a positive pregnancy test result; 19) Those who cannot stop ingesting grapefruit, dragon fruit, mango, lime, star fruit and other fruits or related products that affect metabolic enzymes within 48 hours before the first use of the investigational products and during the test; 20) Other conditions judged by the investigator to be inappropriate for enrollment.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, China

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