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

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 injection serves as the active control and is administered in an open-label manner.

The study will be conducted across 5 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol/kg) and 1 active control cohort of insulin degludec (0.4 U/kg [2.4 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 subjects.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Drug: UBT38006; Drug: Placebo; Drug: Insulin Degludec Injection

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yu Huang; Phone Number: +86 15940441913; Email: huangyu_0518@tul.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; s.c, single dose	Drug: Placebo; Ascending single doses - 4 dose levels
Experimental: UBT38006; s.c, single dose	Drug: UBT38006; Ascending single doses - 4 dose levels
Active Comparator: Active Control; 0.4U/kg Insulin Degludec Injection，single subcutaneous injection	Drug: Insulin Degludec Injection; single subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,..	Baseline to Day43

Secondary Outcome Measures

Outcome Measure	Time Frame
GIRmax	Baseline to Day43
Tmax,GIR	Baseline to Day43
AUCGIR	Baseline to Day43
Cmax	Baseline to Day43
Tmax	Baseline to Day43
t1/2z	Baseline to Day43
AUC0-t	Baseline to Day43
AUCGIR,0-t	Baseline to Day43

Collaborators and Investigators

• Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 19, 2026
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): October 25, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; insulin degludec
• Other Study ID Numbers: TUL-UBT38006（Ⅰ-1）202509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No