Multiple Ascending Dose (MAD) Study of IMT-002 in HLA-DQ8-positive Type 1 Diabetes
Public ClinicalTrials.gov record NCT04625595. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04625595
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
- 350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule Drug
- 700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule Drug
- 1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule Drug
- 1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 9, 2020 (Actual)
- Primary completion
- May 11, 2021 (Actual)
- Completion
- Jul 31, 2021 (Actual)
- Last update posted
- Aug 25, 2021
2020 – 2021
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Prosciento, Inc. | Chula Vista | California | 91911 | — |
| Barbara Davis Center | Aurora | Colorado | 80045 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04625595, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2021 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04625595 live on ClinicalTrials.gov.