A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects

NCT06350812 | Completed Phase 1

• 1 other identifier: PB119110
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pharmacokinetic profile

  From the first dose (Day 1 ) of study drug until 20 week

• Pharmacokinetic profile

  From the first dose (Day 1 ) of study drug until 20 week

• Pharmacokinetic profile

  From the first dose (Day 1 ) of study drug until 20 week

• Pharmacokinetic profile

  From the first dose (Day 1 ) of study drug until 20 week

• Effectiveness index

  week 20

Study Arms (2)

PB-119

EXPERIMENTAL

PB-119 administered on the first day of week 1-20 according to the dose-escalation design

Drug: PB-119

Placebo

PLACEBO COMPARATOR

Matched placebo administered on the first day of week 1-20 according to the dose-escalation design

Drug: Placebo

Interventions

PB-119 DRUG

Administered subcutaneously once a week

PB-119

Placebo DRUG

Administered subcutaneously once a week

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese male or female subjects aged 18-60 years (both inclusive).
• Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI)
• ≥30.0 kg/m2 at screening.
• Weight change \<5% in the past 3 months before screening.

You may not qualify if:

• Fasting Plasma Glucose（FPG） ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
• FPG \<3.9 mmol/L at screening and/or a history of hypoglycemia.
• History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
• Abnormal Thyroid-Stimulating hormone(TSH), Serum Free Triiodothyronine（FT3）, Serum Free Thyroxine（FT4） or diagnosed thyroid dysfunction
• 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）
• Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
• Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at screening or randomization.
• 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.
• Serum amylase or lipase \> 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
• Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.
• 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 before screening.

Sponsors & Collaborators

• PegBio Co., Ltd.: lead

Study Sites (1)

The Third XIANGYA Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guoping Yang, Ph D

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Ping Jin, Ph D

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 5, 2024
• Study Start: May 27, 2024
• Primary Completion: November 16, 2024
• Study Completion: December 16, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)