New diabetes shot UBT38006 enters first human safety trial
NCT ID NCT07630233
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times
Summary
This early-stage trial tests a single injection of UBT38006 in 43 healthy adult men to see if it is safe and how the body processes it. Participants receive either the drug, a placebo, or an active comparator (insulin degludec). The goal is to gather safety data and measure drug levels in the blood, not yet to treat diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- UBT38006 injection
- What this could lead to
- If successful, this could point toward a new, longer-acting diabetes treatment that requires fewer injections.
- What could go wrong
- This is a very early Phase 1 trial in only 43 healthy men, not people with diabetes. It primarily checks safety, not effectiveness, and many early-stage drugs fail to advance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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);
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, China
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