A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.
Study Details
Study Description
Brief Summary
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects. The study consists of three dose groups, each of which is planned to include 12 subjects (9 receiving the study drug and 3 receiving placebo), for a total of 36 patients. Subjects will receive 12 weeks of treatment after screening and complete 8 weeks of safety follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PB-718 Low dose level of PB-718 administered on the first day of week 1-12 according to the dose-escalation design Medium dose level of PB-718 administered on the first day of week 1-12 according to the dose-escalation design High dose level of PB-718 administered on the first day of week 1-12 according to the dose-escalation design |
Drug: PB-718
Administered subcutaneously once a week
|
| Placebo Comparator: Placebo Matched placebo administered on the first day of week 1-12 according to the dose-escalation design |
Drug: Placebo
Administered subcutaneously once a week
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (20 week)]
Secondary Outcome Measures
- Pharmacokinetic profile [From the first dose (Day 1 ) of study drug until 12 week]
Cmax
- Pharmacokinetic profile [From the first dose (Day 1 ) of study drug until 12 week]
Tmax
- Pharmacokinetic profile [From the first dose (Day 1 ) of study drug until 12 week]
AUC0-tau
- Pharmacokinetic profile [From the first dose (Day 1 ) of study drug until 12 week]
AUC0-last
- Pharmacokinetic profile [From the first dose (Day 1 ) of study drug until 12 week]
t1/2
- Proportion of participants with ≥5% weight loss [week 12]
- Change in body weight from baseline [Week12]
- Change in FPG from baseline [week 12]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Chinese male or female subjects aged 18-60 years (both inclusive).
-
Body weight ≥70 kg(male) or 60 kg(femle), and body mass index (BMI) ≥28.0 kg/m2 at screening.
-
Weight change <5% in the past 3 months before screening.
Exclusion Criteria:
-
FPG ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
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FPG <3.9 mmol/L at screening and/or a history of hypoglycemia.
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History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
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Abnormal TSH, FT3, FT4 or diagnosed thyroid dysfunction
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History of multiple endocrine neoplasia syndrome type 2 (MEN-2) or medullary thyroid carcinoma (MTC).
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Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
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Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening or randomization.
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PR intervals > 210 msec and/or QRS > 120 msec and/or QTcF > 450 msec at screening or randomization.
-
Serum amylase or lipase > 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
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Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.
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Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening
-
History of bariatric surgery for weight loss 1 year before screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Beijing | Beijing | China | 100191 |
Sponsors and Collaborators
- PegBio Co., Ltd.
Investigators
- Principal Investigator: Dongyang liu, PhD, Peking University Third Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PB718101