Status:
UNKNOWN
A Clinical Study of BG136 Injection in Healthy Chinese Volunteers
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascen...
Detailed Description
This is a first-in-human, randomized, double-blind, placebo-controlled clinical trial in healthy subjects. The trial consists of two parts: Part 1: a single ascending dose (SAD) study with seven dose ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 6 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05984368
Start Date
August 18 2023
End Date
May 6 2024
Last Update
August 30 2023
Active Locations (1)
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1
Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Qingdao, Shandong, China, 266003