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New treatment option for Healthy Adult Male
Official title Single-ascending Dose Study of HEC-151 Injection
ClinicalTrials.gov ID: NCT07376200
What this study is testing
What is HEC-151 Injection?
HEC-151 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy adult male.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, men only. Healthy volunteers may be eligible.
You may be able to join if
- Voluntarily participate in the trial and sign the informed consent form, understanding and abiding by the research procedures;
- When signing the informed consent form, men aged 18-45 years old (including the boundary value) are eligible;
- During the screening process, male people with a body weight of ≥ 50 kg and a body mass index (BMI) of ≥ 19.0 and ≤ 24.0 kg/m2 are included;
- Normal glucose tolerance [3.9 mmol/L \< fasting blood glucose (FPG) \< 6.1 mmol/L, and 2-hour post-glucose tolerance test (OGTT) blood glucose after...
- Normal results of insulin release test (IRT), or abnormal results but judged by the researcher to have no clinical significance;
You likely can't join if
- Participants with abnormal medical histories or surgical histories judged clinically significant by the researchers, or currently suffering from any...
- Participants who have a known severe allergic history or are allergic to the test drugs and any of their components;
- Participants who had severe trauma or undergone surgery within 90 days before the screening, or plan to undergo major surgery during the study;
- Participants who have a history of hypoglycemia or hyperglycemia within 90 days before the screening, or have a family history of diabetes...
- Participants who have donated blood or suffered significant blood loss (≥ 400 mL) within 90 days before the screening, or plan to donate blood during...
- Participants who have acute diseases or concurrent medication use from the signing of the informed consent form to the first administration of the...
See the full eligibility criteria
- Voluntarily participate in the trial and sign the informed consent form, understanding and abiding by the research procedures;
- When signing the informed consent form, men aged 18-45 years old (including the boundary value) are eligible;
- During the screening process, male people with a body weight of ≥ 50 kg and a body mass index (BMI) of ≥ 19.0 and ≤ 24.0 kg/m2 are included;
- Normal glucose tolerance [3.9 mmol/L \< fasting blood glucose (FPG) \< 6.1 mmol/L, and 2-hour post-glucose tolerance test (OGTT) blood glucose after sugar intake \< 7.8 mmol/L];
- Normal results of insulin release test (IRT), or abnormal results but judged by the researcher to have no clinical significance;
- Glycated hemoglobin (HbA1c) \< 5.7%;
- During the study period, there are no plans for reproduction, sperm collection, or sperm donation, and are willing to take effective contraceptive measures throughout the study period until 3 months after the...
- Participants with abnormal medical histories or surgical histories judged clinically significant by the researchers, or currently suffering from any diseases in the endocrine system, blood system, cardiovascular system...
- Participants who have a known severe allergic history or are allergic to the test drugs and any of their components;
- Participants who had severe trauma or undergone surgery within 90 days before the screening, or plan to undergo major surgery during the study;
- Participants who have a history of hypoglycemia or hyperglycemia within 90 days before the screening, or have a family history of diabetes (first-degree direct relatives);
- Participants who have donated blood or suffered significant blood loss (≥ 400 mL) within 90 days before the screening, or plan to donate blood during the study;
- Participants who have acute diseases or concurrent medication use from the signing of the informed consent form to the first administration of the drug;
- Participants whose vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray examination, etc. results are abnormal and judged by the researchers to have clinical significance;
- Participants whose test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), combined human immunodeficiency virus antigen antibody (HIV), or syphilis spirochete antibody (TP) are positive;
- Participants who have a history of drug abuse or drug use, or whose urine drug screening is positive before the screening;
- Participants who have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, health supplements (except for regular supplementary vitamins and calcium) within 30 days before the screening;
- Participants who have participated in any clinical research of drugs or devices (defined as receiving the test drugs or devices) within 90 days before the screening;
- Participants who have received any vaccine within 30 days before the screening, or plan to receive any type of vaccine during the study;
- Participants who smoke more than 5 cigarettes per day within 90 days before the screening, or cannot comply with the smoking prohibition rule during the study;
- Participants who frequently drink alcohol, that is, consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or have a positive alcohol breath test...
- Participants who consume excessive tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 mL) or food (such as chocolate) every day within 90 days before the screening, or during the study;
- Participants who have used special diets (including dragon fruit, mango, pomelo, etc.) and/or xanthine diet (salmon, sardines, liver, kidney, etc.) or have other factors affecting drug absorption, distribution...
- Participants who have had significant changes in diet or exercise habits within 90 days before the screening, or have engaged in intense exercise before the signing of the informed consent form to the use of the test...
- Participants who have difficulty in venous blood collection, or cannot tolerate venipuncture, or have a history of fainting or hematemesis;
- Participants who, in the researcher's opinion, have other factors that are not suitable for participating in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Bishan, China
- Bishan, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Bishan, China; Bishan, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.