Single-dose subcutaneous UBT38006 in healthy adult males

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, randomized, double-blind, placebo- and active-controlled, parallel-group Phase 1 trial evaluating a single ascending dose of UBT38006 given by subcutaneous injection in healthy adult male participants. The study includes four dose-escalation cohorts (1, 3, 6, and 12 nmol/kg) and two active-control cohorts using insulin degludec and insulin icodec to provide reference PK/PD profiles. Primary endpoints focus on safety and tolerability, including local reactions, while pharmacokinetic and pharmacodynamic measurements characterize blood concentration and biological effects. The design uses a planned 6-cohort structure with specific randomization ratios per cohort. Enrollment is limited to healthy men aged 18-45 without diabetes, with strict inclusion/exclusion criteria and contraception requirements.

Why it matters

Who can join: the full rules

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);

Where it's running

• The Second Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Yu Huang
• Email: huangyu_0518@tul.com.cn
• Phone: +86 15940441913

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lifestyle change program to help type 2 diabetes go into remission in Pakistan

  This study tests whether a structured, plant-predominant lifestyle program can put adults with type 2 diabetes in Lahore, Pakistan into remission for the first six months.

  Recruiting at 2 sites Green International University · Lahore, Punjab Province and 1 other locations · NCT07912944

• Colchicine for preventing cardiovascular disease in adults with type 2 diabetes

  A 24-week study will test whether low-dose colchicine can help protect blood vessels in adults with type 2 diabetes who have not yet developed artery disease, compared with a placebo.

  Recruiting Phase 2 Tan Tock Seng Hospital · Singapore, Singapore · NCT07837934

• MWN105 injection in overweight or obese adults you may join

  This early-phase trial tests whether MWN105 is safe and tolerable in overweight or obese adults in China, using a placebo comparison.

  Recruiting Phase 1 Shanghai Minwei Biotechnology Co., Ltd · Kunming, Yunnan · NCT07803809

• MWN109 tablets in adults with type 2 diabetes mellitus

  A phase 2 trial tests MWN109 tablets versus placebo (and against active control semaglutide) to see if the medicine helps adults with type 2 diabetes lower their blood sugar.

  Recruiting Phase 2 Shanghai Minwei Biotechnology Co., Ltd · Beijing, Beijing Municipality · NCT07801820

• Brain-heart axis in adults with type 2 diabetes

  This study tests how brain activity and heart regulation relate to metabolic status in adults with type 2 diabetes to understand cognitive and functional health.

  Recruiting Hacettepe University · Tunceli · NCT07757308

• Digital dietary help for people on GLP-1 therapy to reach better blood sugar and weight

  This trial tests whether adding a digital dietary program (NutriSteppe) to usual care helps adults on GLP-1 medications see better blood sugar control and weight results.

  Recruiting Kazakh Academy of Nutrition · Almaty · NCT07728669

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.