United Bio-Technology's UBT38006 heads toward first Phase 1 data in October
A routine enrollment bump to 53 leaves the Chinese biotech's insulin receptor agonist on track for a single-dose safety and PK readout against degludec and icodec.
Executive Summary
- The sponsor increased planned enrollment in its Phase 1 single-ascending-dose study of UBT38006, a change within the range the operational model treats as routine for a trial that has not yet started recruiting.
- The study measures adverse events, tolerability, and pharmacokinetics and pharmacodynamics of a single subcutaneous dose, benchmarked directly against two already-marketed basal insulins rather than placebo alone.
- UBT38006 enters a target class already populated by dozens of insulin receptor programs from established insulin makers, so its Phase 1 data will be read against an established mechanism rather than a novel one.
- The readout due around the trial's primary completion date will be the first human evidence on whether the molecule's safety and exposure profile can compete with the degludec and icodec benchmarks built into its own design.
The update
United Bio-Technology (Hengqin) Co., Ltd. registered an increase in anticipated enrollment for NCT07630233, its Phase 1 study of subcutaneous UBT38006, from 43 to 53 participants. The trial has not yet started recruiting and carries a start date of June 19, 2026, with a primary completion date of October 25, 2026. The operational model that tracks enrollment shifts treats this change as typical for the design, since it flags moves of 20% or more and this trial's structure places the change within the routine band. NCT07630233+1A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult MalesNCT07630233A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult MalesJul 20, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the study tests
The design is a single-center, randomized, quadruple-masked, placebo- and active-controlled study in healthy adult males, using a single-ascending-dose structure across four escalating UBT38006 cohorts (1, 3, 6, and 12 nmol/kg) plus two active-control cohorts. The primary endpoint is the incidence of adverse events, adverse drug reactions, and serious adverse events measured from baseline through day 43. Secondary endpoints cover pharmacokinetic and pharmacodynamic measures including Cmax, Tmax, AUC, and glucose infusion rate parameters that characterize how the drug is absorbed, cleared, and how it lowers blood glucose. NCT07630233A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult MalesNCT07630233
The added comparator
The sponsor's most recent protocol update added a sixth cohort, an open-label active-control arm dosing insulin icodec at 1.25 U/kg, alongside the existing insulin degludec active-control cohort dosed at 0.4 U/kg. Insulin degludec and insulin icodec are both approved, once-daily and once-weekly basal insulins respectively marketed by other sponsors in diabetes indications; UBT38006 is tested here only in healthy volunteers, not yet in a diabetes population. Running the new molecule against both benchmarks in the same study gives the eventual readout a direct comparison to two commercial standards rather than to placebo alone. NCT07630233A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult MalesNCT07630233
The competitive field
Insulin receptor agonism is not a novel mechanism: peer programs exist across sponsors including Novo Nordisk's insulin icodec, Eli Lilly's insulin lispro-aabc and LY3938577, Sanofi's iGlarLixi, and Gan & Lee Pharmaceuticals' GZR4, spanning Phase 1 through Phase 4. None of these programs functions as a direct head-to-head comparator to UBT38006 in this trial; they instead form the broader readthrough field this asset will eventually be measured against on dosing frequency, tolerability, and glucose control. UBT38006's own trial portfolio consists of this single Phase 1 study, with no other trials or terminations on record for the molecule. NCT07630233A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult MalesNCT07630233
Sponsor context
The United Bio-Technology (Hengqin) Co., Ltd. runs a broader pipeline of eight trials, split across four not-yet-recruiting, two completed, and two recruiting studies, indicating this program sits within an active but early-stage portfolio. The trial's protocol has changed once since its first posting in June 2026, limited to the enrollment count adjustment, which the registry-churn proxy for this study reads as stable. NCT07630233A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult MalesNCT07630233
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.