A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of a Single Oral Dose of UBT48128 Tablets in Healthy Participants

This study is a single-center, randomized, double-blind, placebo-controlled, first-in-human, dose-escalation trial (with an open-label design for the first dose cohort), designed to evaluate the safety, tolerability, and PK/PD characteristics of UBT48128 tablets following single oral administration in healthy adult participants, the effect of food on the PK characteristics of UBT48128, the biotransformation and mass balance properties of UBT48128 in vivo, and its effect on the QT/QTc interval.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight , Obesity
• Intervention / Treatment: Drug: Placebo; Drug: UBT48128

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jie Wu; Phone Number: 13764097870; Email: wujie@tul.com.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
      • Contact: Guoping Yang; Phone Number: 13974817168

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participants must be able to communicate well with the investigator, have fully understood this study, participate voluntarily, understand and comply with all requirements of this study, and sign a written informed consent form before the trial.
2. Aged 18-55 years (inclusive) at the time of signing the informed consent, healthy Chinese males or females.
3. At screening, male body weight > 60 kg and female body weight > 50 kg, with a body mass index (BMI) within 19.0-30.0 kg/m² (inclusive).
4. Body weight change within 3 months prior to screening ≤ 5% (based on self-report).
5. At screening, glycated hemoglobin (HbA1c) < 6.5% and fasting blood glucose < 6.1 mmol/L.
6. Female participants of childbearing potential or male participants must have no plan to reproduce or donate sperm/ova from the time of signing the informed consent form until 3 months after dosing, and must voluntarily adopt the contraceptive measures specified in the study.

Exclusion Criteria:

1. A prior history of, or suspected hypersensitivity or allergic reactions to the investigational product ingredients or other GLP-1 receptor agonist drugs, or being of an allergic constitution (allergic to multiple drugs and foods);
2. Suffering from clinically significant diseases/abnormalities within 1 year prior to screening or currently having clinically significant diseases/abnormalities (including but not limited to diseases of the neuropsychiatric, cardiovascular, respiratory, blood and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, and skeletal systems);
3. A personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or hereditary diseases that predispose to medullary thyroid carcinoma;
4. A history of pancreatitis or concurrent symptomatic pancreatic disease at screening;
5. A history of cholecystitis, or a past history of gallbladder disease that has been symptomatic (except for participants who have previously undergone cholecystectomy and are judged by the investigator as eligible for enrollment);
6. Symptomatic hypoglycemia requiring medical intervention within 12 months prior to screening, or recurrent symptomatic hypoglycemia (≥ 2 episodes) within the past 6 months, or hypoglycemia unawareness;
7. Optic neuropathy at screening, or high-risk factors for non-arteritic anterior ischemic optic neuropathy (NAION) within 6 months prior to screening;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UBT48128; Ascending single doses - 6 dose levels	Drug: UBT48128; Administered orally
Placebo Comparator: Placebo; Ascending single doses - 6 dose levels	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,..	Baseline to Day 6 and Day 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax	Baseline to Day 6 and Day 13
Tmax	Baseline to Day 6 and Day 13
AUC0-t	Baseline to Day 6 and Day 13
AUC0-∞	Baseline to Day 6 and Day 13
λz	Baseline to Day 6 and Day 13
t1/2	Baseline to Day 6 and Day 13
CL/F	Baseline to Day 6 and Day 13
Vz/F	Baseline to Day 6 and Day 13
MRT	Baseline to Day 6 and Day 13

Collaborators and Investigators

• Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 29, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: TUL-UBT48128（I-3）202610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No