Multiple Ascending Dose (MAD) Study of IMT-002 in HLA-DQ8-positive Type 1 Diabetes

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

May 11, 2021

Study Completion Date

July 31, 2021

Conditions
Type1 Diabetes
Interventions
DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

Trial Locations (3)

80045

Barbara Davis Center, Aurora

91911

Prosciento, Inc., Chula Vista

98057

Rainier Clinical Research Center, Renton

Sponsors
All Listed Sponsors
collaborator

WCCT Global

INDUSTRY

lead

Immunomolecular Therapeutics, Inc.

INDUSTRY

NCT04625595 - Multiple Ascending Dose (MAD) Study of IMT-002 in HLA-DQ8-positive Type 1 Diabetes | Biotech Hunter | Biotech Hunter