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Not yet recruitingPhase 1

First safety test of UBT48128 tablets in healthy adults

Tests single oral doses of UBT48128 tablets in healthy adults.

Key facts

Who runs it
The United Bio-Technology (Hengqin) Co., Ltd.
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Status
Not yet recruiting
Phase
Phase 1
People taking part
60 people, planned
Starts
29 Nov 2026
Expected to end
30 Dec 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • UBT48128
  • Placebo
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy Chinese adults aged 18-55 to test a single oral dose of UBT48128 tablets for safety and how the body handles it.

Age
18 to 55 years
Sex
Men and women can join.
Disease stage
Healthy volunteers only; blood sugar must be normal (HbA1c below 6.5% (48 mmol/mol) and fasting blood glucose below 6.1 mmol/L (110 mg/dL)).
Earlier treatment
No earlier treatment is required. Body weight must not have changed by more than 5% in the 3 months before screening.

Main reasons for not taking part

  • Allergy to the trial drug or to other GLP-1 receptor agonist drugs
  • Current or recent serious illness in the past year
  • Personal or family history of medullary thyroid cancer or MEN2
  • History of pancreatitis or gallbladder disease with symptoms
  • Severe low blood sugar needing medical care in the past 12 months

This trial only enrols healthy participants. The registry sentence this rests on: Aged 18-55 years (inclusive) at the time of signing the informed consent, healthy Chinese males or females.

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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
  • Aged 18-55 years (inclusive) at the time of signing the informed consent, healthy Chinese males or females
  • 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)
  • Body weight change within 3 months prior to screening ≤ 5% (based on self-report)
  • At screening, glycated hemoglobin (HbA1c) < 6.5% and fasting blood glucose < 6.1 mmol/L
  • 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

Who cannot take part

  • 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)
  • 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)
  • A history of pancreatitis or concurrent symptomatic pancreatic disease at screening
  • 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)
  • 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
  • Optic neuropathy at screening, or high-risk factors for non-arteritic anterior ischemic optic neuropathy (NAION) within 6 months prior to screening
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • UBT48128Treatment being tested

    Ascending single doses - 6 dose levels

  • PlaceboPlacebo, for comparison

    Ascending single doses - 6 dose levels

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
First safety test of UBT48128 tablets in healthy adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07922798, who can take part
Record updated
6 November 2026