A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Sub… (NCT07630233) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males
43 participantsStarted 2026-06-19
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is Phase 1 and described as being in healthy adult males only — does that mean it's still too early in development for someone who actually has Type 2 Diabetes to participate, and what does that tell us about how much is currently known about this drug's safety?
2Since the trial is listed as 'not yet recruiting,' is there any estimated timeline for when it might open, and would it even make sense to wait for it rather than starting an established treatment now?
3The main thing being measured here is how often side effects and serious adverse events occur — what does it mean for my situation that researchers are still at the stage of figuring out basic safety, rather than whether the drug actually helps manage blood sugar?
4UBT38006 is given as a single subcutaneous injection in this study — do you know anything about what kind of drug this is or how it's expected to work for Type 2 Diabetes, so we can weigh it against what I'm already considering?
5Given that this is a very early-stage trial focused on healthy volunteers rather than patients with T2DM, would it make more sense for me to focus on proven treatments or other trials that are further along, and revisit this one later if the results look promising?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,..
Timeframe: Baseline to Day43
Trial details
NCT IDNCT07630233
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.