A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects

PB119110

The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.

2024-05-27

2025-04-29

2025-04-29

Early phase I

32

Inclusion Criteria: 1. Chinese male or female subjects aged 18-60 years (both inclusive). 2. Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI) ≥30.0 kg/m2 at screening. 3. Weight change \<5% in the past 3 months before screening. Exclusion Criteria: 1. Fasting Plasma Glucose（FPG） ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes 2. FPG \<3.9 mmol/L at screening and/or a history of hypoglycemia. 3. History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones. 4. Abnormal Thyroid-Stimulating hormone(TSH), Serum Free Triiodothyronine（FT3）, Serum Free Thyroxine（FT4） or diagnosed thyroid dysfunction 5. History of multiple endocrine neoplasia syndrome type 2 (MEN-2) , medullary thyroid carcinoma (MTC) or Category 4 and above thyroid nodules by Thyroid ultrasound Chinese Ultrasound Thyroid Imaging Reporting and Data System （C-TIRADS） 6. Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening 7. Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at screening or randomization. 8. Time history from the starting point of P-wave to the starting point of QRS wave（PR intervals ）\> 210 msec and/or QRS complex（QRS） \> 120 msec and/or Corrected QT Interval（QTcF） \> 450 msec at screening or randomization. 9. Serum amylase or lipase \> 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis. 10. Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L. 11. Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening 12. History of bariatric surgery for weight loss before screening.

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2024-05-29