A Clinical Study of BG136 Injection in Healthy Chinese Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984368
• Other study ID #: BG136211213
• Status: Recruiting
• Phase: Phase 1
• Start date: August 18, 2023
• Est. completion date: May 6, 2024

Study information

• Verified date: August 2023
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yu Cao, doctor
• Phone: 86-18661809090
• Email: caoyu1767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)

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 groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose groups), with two subjects enrolled in the 2 mg group (all receiving the test drug), and eight subjects enrolled in each of the remaining groups (six test drug and two placebo); Part 2: a multiple ascending dose (MAD) study with seven dose groups: two subjects (six test drug and two placebo); and Part III: a randomized, double-blind, placebo-controlled clinical trial in healthy subjects, with a randomized, double-blind, placebo-controlled clinical trial in healthy subjects. Part II: Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each including 8 healthy subjects (6 test drug, 2 placebo).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: May 6, 2024
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BG136
Subjects injected with BG136 in Part 1 and Part 2
• Placebo
Subjects injected with Placebo in Part 1 and Part 2

Locations

Country	Name	City	State
China	Affiliated Hospital of Qingdao University Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	up to 14 days
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	up to 14 days
Primary	Area under the plasma concentration versus time curve (AUC)0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	up to 14 days
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	up to 14 days