Testing BG136 Injection in Healthy Chinese Volunteers

First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation and Multiple Dose Escalation Phase I Clinical Trial of BG136 for Injection in Healthy Subjects

This study is testing a new injection called BG136 in healthy Chinese volunteers to see if it's safe and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT05984368 on ClinicalTrials.gov

What this trial studies

This clinical trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of BG136 in healthy Chinese volunteers. The trial consists of two parts: a single ascending dose (SAD) study with multiple dose groups and a multiple ascending dose (MAD) study. Each part includes a combination of test drug and placebo administration to assess the effects of varying doses. The study aims to gather critical data on the drug's safety profile and pharmacokinetics in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy Chinese males and females aged 18-55 with specific weight and BMI criteria.

Not a fit: Patients with recent medical conditions or surgeries, or those with significant health issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide valuable insights into the safety and dosing of BG136, potentially leading to its future use in treating various conditions.

How similar studies have performed: While this approach is common in early-phase drug testing, the specific drug BG136 is novel and has not been tested in previous studies.

Eligibility criteria

Inclusion Criteria:

* Chinese male or female subjects aged 18-55 years (including the threshold);
* Weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI): 19.0-26.0 kg/m2 (including borderline values);
* Subjects understand and comply with the study process, can communicate well with the investigator, volunteer to participate in the trial and sign an informed consent form.

Exclusion Criteria:

* Diseases to be excluded due to clinical abnormalities within 3 months prior to screening, including but not limited to neurological/psychiatric, cardiovascular, hematological and lymphatic, immune, gastrointestinal, urinary, endocrine, metabolic, and skeletal conditions. History of diseases of the urinary, endocrine, respiratory, metabolic and skeletal systems.
* History of comorbid gastrointestinal related disorders
* Those who have had surgery within 3 months prior to screening or plan to have surgery during the study period；
* Screening subjects whose vital signs, physical examination, routine blood, urine, blood biochemistry, coagulation function, and electrocardiogram are judged by the investigator to be abnormal and clinically significant；
* Subject's imaging determined by the investigator to be clinically significant for abnormalities；
* Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody screening, human immunodeficiency virus (HIV) antibody screening, treponema pallidum antibody (TP-Ab) any test positive；
* History of food or drug allergies or other allergic diseases；
* History of substance abuse in the 12 months prior to screening, or drug use in the 3 months prior to screening, or a positive urine drug screen；
* Positive breath test results for alcohol or regular alcohol consumption in the 6 months prior to screening, i.e., an average of more than 14 units of alcohol per week (1 unit ≈ 200 mL of beer at 5% alcohol or 25 mL of spirits at 40% alcohol or 85 mL of wine at 12% alcohol), or inability to abstain from alcohol consumption for 48 hours prior to the first dose of the medication and for the entire study period；
* Smokers who smoked an average of ≥5 cigarettes per day in the 3 months prior to screening or who could not give up smoking 48 hours prior to the first dose and throughout the study period；
* Those who have received a blood transfusion or used blood products ≥ 400 mL or 2 units within 3 months prior to screening, or those who have lost ≥ 400 mL of blood within 6 months, or those who have donated blood within 3 months；
* Participated in another clinical trial within 3 months prior to screening and took the trial drug or used the trial device；
* Any prescription (including vaccines), over-the-counter medications used within 4 weeks prior to screening；
* Those who have used herbal medicines or health supplements for the treatment and/or prevention of their own disease within 2 weeks prior to screening；
* Persons with special dietary requirements who are unable to follow a standardized diet or who are unable to avoid xanthine-rich beverages or foods or fruits or fruit juices that may interfere with metabolism for 48 hours prior to dosing and up to study completion;
* Those who have difficulty in collecting blood from veins or who suffer from needle;
* Women who are pregnant, breastfeeding, or who have had unprotected sex within 2 weeks prior to screening, or who have had a positive pre-test pregnancy test;
* Male subjects (or their partners) or female subjects who are planning a pregnancy, sperm donation, or oocyte donation from the time of signing the Informed Consent Form until 3 months after the end of the administration of the medication;
* Those who do not wish to use one of the medically approved non-pharmacological contraceptives (e.g., intrauterine device or condom) during the trial period;
* Subjects deemed unsuitable by the investigator to participate in the study.

Where this trial is running

Qingdao, Shandong

• Affiliated Hospital of Qingdao University Phase I Clinical Research Center — Qingdao, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Yu Cao, doctor — The Affiliated Hospital of Qingdao University
• Study coordinator: Yu Cao, doctor

Conditions Healthy