CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule +3 moredrug
Likely dose
350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsulefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04625595
NCT04625595Phase 1Completed
CompareCT.gov

A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients With Type 1 Diabetes and HLA-DQ8

Immunomolecular Therapeutics, Inc.·interventional·Posted Nov 12, 2020·Updated Aug 25, 2021

In Brief

A Phase 1 clinical trial evaluating 350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule, 700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule, and 2 other interventions for Type1 Diabetes. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

This study is designed to characterize the safety, steady-state pharmacokinetics (PK) of IMT-002, and will serve as a dose range identification for the pharmacodynamic effect of blocking self-antigen presentation in adults with type 1 diabetes (T1D) having the human leukocyte antigen (HLA)-DQ8 gene.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType1 Diabetes
CountriesUnited States
CollaboratorsWCCT Global

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedNov 12, 2020
Enrollment StartNov 9, 2020
Primary CompletionMay 11, 2021
Study CompletionJul 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.6 years ago

Interventions

350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuledrug

Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily

700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuledrug

Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily

1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuledrug

Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily

1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsuledrug

Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily