ClinicalTrials.gg
Not yet recruitingNCT07922798Updated Nov 6, 2026

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

A Phase 1 interventional study of UBT48128 and Placebo in Overweight , Obesity, sponsored by The United Bio-Technology (Hengqin) Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The United Bio-Technology (Hengqin) Co., Ltd. (part of The United Laboratories International Holdings Limited) · Phase 1, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight , Obesity

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

The United Bio-Technology (Hengqin) Co., Ltd. is the lead sponsor of 13 studies on the registry; 10 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 (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, (HbA1c) \< 6.5% and fasting blood glucose \< 6.1 mmol/L.
  6. Female participants of 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 measures specified in the study.

Exclusion criteria

Exclusion Criteria:

  1. A prior history of, or suspected or allergic reactions to the product ingredients or other GLP-1 receptor agonist drugs, or being of an allergic constitution (allergic to multiple drugs and foods);
  2. Suffering from 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;
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    UBT48128

    Ascending single doses - 6 dose levels

    Drug: UBT48128

  • Placebo comparator
    Placebo

    Ascending single doses - 6 dose levels

    Drug: Placebo

Interventions

  • DrugUBT48128

    Administered orally

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  1. incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,..

    Time frame: Baseline to Day 6 and Day 13

Secondary outcomes

  1. Cmax

    Time frame: Baseline to Day 6 and Day 13

  2. Tmax

    Time frame: Baseline to Day 6 and Day 13

  3. AUC0-t

    Time frame: Baseline to Day 6 and Day 13

  4. AUC0-∞

    Time frame: Baseline to Day 6 and Day 13

  5. λz

    Time frame: Baseline to Day 6 and Day 13

  6. t1/2

    Time frame: Baseline to Day 6 and Day 13

  7. CL/F

    Time frame: Baseline to Day 6 and Day 13

  8. Vz/F

    Time frame: Baseline to Day 6 and Day 13

  9. MRT

    Time frame: Baseline to Day 6 and Day 13

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 1 month is below that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Nov 29, 2026
Primary completionEst.
Dec 29, 2026
CompletionEst.
Dec 30, 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07922798
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 29, 2026 (estimated)
Primary completion
Dec 29, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Nov 6, 2026

Study contacts

Jie Wu
Contact
wujie@tul.com.cn
13764097870

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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