A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500

Part of paid clinical trials in Chula Vista, California.

Sponsor
Portal Diabetes, Inc.
Study ID
NCT07341373
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Portal Insulin U-500 — DRUG
    Intraperitoneal delivery of a single dose at 0.1 U/kg during an euglycemic clamp
  • Portal Insulin U-500 — DRUG
    Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp
  • Portal Insulin U-500 — DRUG
    Intraperitoneal delivery of a single dose at 0.3 U/kg during an euglycemic clamp
  • Humulin R U-500 — DRUG
    Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp
  • Lyumjev U-100 Insulin — DRUG
    Subcutaneous delivery of a single dose at 0.2 U/kg during an euglycemic clamp

Study Details

The goal of this clinical trial is to assess the safety of a new U500 insulin formulation and to determine how rapidly it is absorbed and how long it takes to act when administered intraperitoneally. The trial will be conducted in people with Type 1 Diabetes. The main questions it aims to answer are: Is the drug safe and tolerable when administered intraperitoneally? How fast is it absorbed, and how long does it take to act? Researchers will compare the investigational product (PI-U500) with Humulin R U500 administered intraperitoneally and Lyumjev U100 administered subcutaneously. Participants will undergo a 12-hour clamp procedure in which their blood glucose will be maintained stable via glucose infusion at variable rates after a single intraperitoneal injection of the insulin formulation.

Key Dates

Start date
Feb 10, 2026
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part A, Group 1, Single Ascending Dose
    Participants will receive PI-U500 intraperitoneally at 0.1 U/kg, then 0.2 U/kg and lastly 0.3 U/kg
  • Other: Part B, Group 2
    A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.2 U/kg of PI-U500. All administered intraperitoneally.
  • Other: Part B, Group 3
    A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.3 U/kg of PI-U500. All administered intraperitoneally.
  • Other: Part B, Group 4
    A three-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.3 U/kg of PI-U500, also intraperitoneally.
  • Other: Part B, Group 5
    A two-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally.
  • Other: Part B, Group 6
    A three-way crossover where participants will receive 0.2 U/kg of each of the drugs sequentially, but the order will be randomized into three options: * Option 1: 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally, and finally 0.2 U/kg of PI-U500 intraperitoneally. * Option 2: 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally , followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously. * Option 3: 0.2 U/kg of PI-U500 intraperitoneally , followed by 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, and finally 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally.

Primary Outcome Measure

Safety: Incidence of adverse events [ Time Frame: From enrollment until the follow-up visit, an average of 2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
ProSciento, Inc.Chula VistaCalifornia91911
Julena Shifter
[email protected]
+16199346286

Find similar trials in Chula Vista, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
ProSciento, Inc.· Chula Vista, CA

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