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Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07630233

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males

A Phase 1 study testing UBT38006, Insulin Degludec Injection and Insulin Icodec Injection in people with Type 2 Diabetes Mellitus (T2DM), run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec and insulin icodec injection serves as the active control and is administered in an open-label manner. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
UBT38006, Insulin Degludec Injection and Insulin Icodec Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteChina
Study dates
17 Jun 2026to 25 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18-45 years (inclusive) at the time of informed consent form (ICF) signing;
  • Sex: Male;
  • Body weight ≥50.0 kg and body mass index (BMI) between 19.0-24.0 kg/m² (BMI = weight [kg] / height² [m²]), inclusive, at Screening;
  • Fasting plasma glucose (FPG) between 3.9-6.1 mmol/L (exclusive of boundary values) at Screening; 2-hour plasma glucose <7.8 mmol/L on oral glucose tolerance test (OGTT) at Screening; insulin release test (IRT) results normal, or abnormal but judged by the Investigator as not clinically significant (NCS)at Screening; glycated hemoglobin (HbA1c) ≤6.0% at Screening;
  • The subject (including his partner) is willing to use adequate and effective contraception voluntarily from Screening through 3 months after administration of the investigational medicinal product (IMP) (see Appendix 2 for details), and has no plan to donate sperm within 3 months after IMP administration;
  • The subject is able to communicate well with the Investigator, has adequate understanding of this study, participates voluntarily, understands and complies with all study requirements, and provides written informed consent.

Who cannot join

  • History of severe hypersensitivity (e.g., allergy to three or more allergens, allergic asthma involving the lower respiratory tract, or allergy requiring systemic corticosteroid therapy) or known hypersensitivity to any component of the investigational medicinal product;
  • History of severe or currently clinically significant disease/condition (including but not limited to diseases of the nervous, cardiovascular, respiratory, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, and skeletal systems, history of malignancy, or neurological or psychiatric disease/condition);
  • History of orthostatic hypotension, syncope, or amaurosis, or first-degree relative with history of diabetes mellitus;
  • Laboratory abnormalities (hematology, blood chemistry, coagulation function, thyroid function, urinalysis, stool routine, etc.) at Screening that are judged by the Investigator as clinically significant;
  • Positive insulin autoantibody (IAA) at Screening;
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody, or Treponema pallidum antibody at Screening;
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  • History of drug abuse, or positive urine drug screen prior to randomization;
  • Clinically significant abnormalities on physical examination, electrocardiogram (ECG), or vital signs (body temperature, pulse, blood pressure);
  • Use of insulin-containing agents within 3 months prior to dosing, or use of any other medication (including traditional Chinese medicine, over-the-counter drugs, etc.) within 30 days prior to dosing;
  • Vaccination with any vaccine within 1 month prior to dosing;
  • History of surgery within 3 months prior to dosing, or planned surgery during the entire study period;
  • History of blood loss or blood donation exceeding 200 mL within 3 months prior to dosing (calculated from the day before dosing);
  • Hemoglobin below the lower limit of normal (LLN);
  • Participation in other interventional clinical trials within 3 months prior to dosing (except for subjects who only underwent screening but were not enrolled, or were enrolled but did not receive treatment);

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yu Huang contact

+86 15940441913

huangyu_0518@tul.com.cn

China1 site, 1 recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

    Hu Wei Chief Pharmacist, +86 13856086475, huwei@ahmu.edu.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of UBT38006 Injection in Healthy Adult Male Subjects

This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec and insulin icodec injection serves as the active control and is administered in an open-label manner.

The study will be conducted across 6 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol/kg) ， 1 active control cohort of insulin degludec (0.4 U/kg [2.4 nmol/kg]) and 1 active control cohort of insulin icodec (1.25 U/kg [7.5 nmol/kg]). The safety and tolerability (including local tolerability) as well as the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single subcutaneous doses of UBT38006 injection will be evaluated in healthy adult male participants.

In Cohort 1 (1 nmol/kg), participants will be randomized in a 4:1 ratio to receive UBT38006 injection or placebo. In Cohorts 2-4 (3, 6, and 12 nmol/kg), participants will be randomized in an 8:2 ratio to receive the corresponding dose of UBT38006 injection or placebo. Participants in Cohort 5 (insulin degludec active control) will receive 0.4 U/kg (2.4 nmol/kg) insulin degludec injection. Participants in the insulin icodec cohort received a subcutaneous injection of insulin icodec at a dose of 1.25 U/kg(7.5 nmol/kg). Cohorts 1-4 will follow a double-blind design, while Cohort 5 and insulin icodec cohort will be open-label.

Being tested
UBT38006, Placebo, Insulin Degludec Injection, Insulin Icodec Injection
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UBT38006Drug

    Ascending single doses - 4 dose levels

  • PlaceboDrug

    Ascending single doses - 4 dose levels

  • Insulin Degludec InjectionDrug

    single subcutaneous injection

  • Insulin Icodec InjectionDrug

    single subcutaneous injection

Study groups in NCT07630233
Study groupRoleWhat they receive
UBT38006Experimentals.c, single dose
Receives: Drug: UBT38006
PlaceboPlacebo comparators.c, single dose
Receives: Drug: Placebo
Insulin Degludec Active ControlActive comparator0.4U/kg Insulin Degludec Injection，single subcutaneous injection
Receives: Drug: Insulin Degludec Injection
Insulin Icodec Active ControlActive comparator1.25U/kg Insulin icodec Injection，single subcutaneous injection
Receives: Drug: Insulin Icodec Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline to Day43

Secondary outcomes (8)

  1. GIRmax

    Measured: Baseline to Day43

  2. Tmax,GIR

    Measured: Baseline to Day43

  3. AUCGIR

    Measured: Baseline to Day43

  4. Cmax

    Measured: Baseline to Day43

  5. Tmax

    Measured: Baseline to Day43

  6. t1/2z

    Measured: Baseline to Day43

  7. AUC0-t

    Measured: Baseline to Day43

  8. AUCGIR,0-t

    Measured: Baseline to Day43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start17 Jun 2026
  3. Primary completion25 Oct 2026 (estimated)
  4. Study completion25 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07630233
Sponsor's protocol ID
TUL-UBT38006（Ⅰ-1）202509
Status last verified
Jul 2026
First submitted
1 Jun 2026
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UBT38006, Insulin Degludec Injection and Insulin Icodec Injection in people with Type 2 Diabetes Mellitus (T2DM), run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yu Huang (+86 15940441913, huangyu_0518@tul.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,.. (time frame: Baseline to Day43). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07630233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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