Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus

Conditions

• Type I Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• OPT101 — DRUG
  Subcutaneous injection.
• OPT101 Placebo to Match (PTM) — OTHER
  5% Dextrose (w/v)

Study Details

This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.

Key Dates

Start date

Apr 10, 2026

Status verified

Feb 2026

Primary completion

May 31, 2026

Completion

Aug 19, 2028

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: OPT101, 1.0mg/kg, 1.5 mg/kg and 2.0 mg/kg
  Part A. 6 subjects will receive 1.0mg/kg OPT101 6 subjects will receive 1.5mg/kg OPT101 6 subjects will receive 2.0mg/kg OPT101
• Experimental: Part B - OPT101 and Placebo to Match
  The highest tolerated dose from Part A will be tested over 48 weeks. 27 subjects (18 investigational product: 9 placebo)
• Experimental: Part C - OPT101 and Placebo to Match
  The highest tolerated dose in Part A will be dosed. 27 subjects (18 investigational product, 9 placebo)

Primary Outcome Measure

Change in C-peptide (ng/mL) [ Time Frame: 48-week ]

Central Contacts

• Lisa Boswell
  303-503-9954
  [email protected]

Locations (5)

Find similar trials in Birmingham, AL

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