Obesity Clinical Trial
Official title:
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
The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | April 29, 2025 |
Est. primary completion date | April 29, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Chinese male or female subjects aged 18-60 years (both inclusive). 2. Body weight =70 kg(male) or 60 kg(femle), 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. 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 TSH, FT3, 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 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. PR intervals > 210 msec and/or QRS > 120 msec and/or 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
PegBio Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events | From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (24 week) | ||
Secondary | Pharmacokinetic profile | Cmax | From the first dose (Day 1 ) of study drug until 20 week | |
Secondary | Pharmacokinetic profile | Tmax | From the first dose (Day 1 ) of study drug until 20 week | |
Secondary | Pharmacokinetic profile | AUC0-tau | From the first dose (Day 1 ) of study drug until 20 week | |
Secondary | Pharmacokinetic profile | AUC0-last | From the first dose (Day 1 ) of study drug until 20 week | |
Secondary | Effectiveness index | Change in body weight from baseline | week 20 | |
Secondary | Effectiveness index | Proportion of participants with =5% weight loss | week 20 |
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