A Clinical Study of BG136 Injection in Healthy Chinese Volunteers

NCT05984368 | Unknown Phase 1

• 1 other identifier: BG136211213
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  up to 14 days

• 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

• Area under the plasma concentration versus time curve (AUC)0-∞

  Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

  up to 14 days

Study Arms (2)

Part 1

EXPERIMENTAL

A single ascending dose (SAD) study divided into 7 dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose group), with 2 mg enrolling 2 subjects (all receiving the test drug) and the remaining 8 subjects in each group (6 test drug, 2 placebo).

Drug: BG136; Drug: Placebo

Part 2

EXPERIMENTAL

Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each group included 8 healthy subjects (6 test drug, 2 placebo).

Drug: BG136; Drug: Placebo

Interventions

BG136 DRUG

Subjects injected with BG136 in Part 1 and Part 2

Part 1; Part 2

Placebo DRUG

Subjects injected with Placebo in Part 1 and Part 2

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Affiliated Hospital of Qingdao University Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

RECRUITING

Study Officials

• Yu Cao, doctor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Cao, doctor

CONTACT

86-18661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials Center of Affiliated Hospital of Qingdao University

Model Details: Single-dose and multi-dose, dose escalation, placebo-controlled study

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 9, 2023
• Study Start: August 18, 2023
• Primary Completion: September 5, 2023
• Study Completion: May 6, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)