Healthy volunteers and adults with autoimmune diseases Other
Conditions
Interventions
Current interventions as of 11/04/2025:
In Part 1, participants will be randomized using simple randomization without stratification to receive either a single Intravenous (IV) Dose A, single IV Dose
Sponsors
Immunovant Sciences GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 11/03/2024: Participants between the ages of 18 and 75 years will be included. Previous participant inclusion criteria: 1. Have a body weight of =50 kg 2. Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule 3. Have adequate venous access, assessed at the time of screening, that allows for IV dosing and/or repeated phlebotomy 4. Are healthy as determined by the Investigator based on a medical evaluation including medical history, physical examination, laboratory tests, and Electrocardiogram (ECG). 5. Are female, not lactating, and of NCBP 6. Are male and have had a vasectomy >6 months prior to the Screening Visit or agree to use contraceptive methods starting at the Screening Visit and continuing throughout the study and for 90 days after the final study treatment administration
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 11/03/2024: Not meeting the inclusion criteria. Previous participant exclusion criteria: 1. Have any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as judged by the Investigator. 2. Have an active malignancy or history of malignancy in the 3 years prior to the Screening Visit (exclusive of non-melanoma skin cancer, cervical cancer in situ or prostate cancer in situ) or any history of malignancy not deemed cured by adequate treatment. 3. Have any clinically significant history of allergic conditions, including drug allergies, anaphylactic reactions, or hypersensitivity to study treatments or components. Participants with currently asymptomatic, seasonal allergies or exercise-induced bronchospasm prior to study treatment administration are eligible. 4. Have undergone any blood loss or phlebotomy with removal of =500 milliliter (mL) of blood within 56 days prior to the Screening Visit. 5. Have received a transfusion of any blood or blood products within 56 days or donated plasma within 7 days prior to the Screening Visit. 6. Have participated in any other study involving an investigational product (IP) within the last 30 days or 5 half-lives, whichever is greater (6 months for anti-neonatal fragment crystallizable receptor [FcRn] therapy), prior to the Screening Visit or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/04/2025: 1. Part 1: Adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation measured using study records up to 13 weeks for SAD, up to 16 weeks for MAD, and 10 weeks for the alternative dose regimen cohort. 2. Part 2: AEs, SAEs, and AEs leading to study treatment discontinuation measured using study records for up to 16 weeks. 3. Part 3: AEs, SAEs, and AEs leading to study treatment discontinuation are measured using study records from Week 12 through Week 108. Previous primary outcome measure from 11/03/2024 to 11/04/2025: 1. Part 1: Adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation measured using study records up to 13 weeks for SAD, up to 16 weeks for MAD, and 10 weeks for the alternative dose regimen cohort. 2. Part 2: AEs, SAEs, and AEs leading to study treatment discontinuation measured using study records up to 16 weeks. Previous primary outcome measure from 04/12/2023 to 11/03/2024: Adverse events (AEs), serious adverse events (SAEs), AEs leading to study treatment discontinuation measured using study records up to 13 weeks for SAD, up to 16 weeks for MAD, and 10 weeks for the alternative dose regimen cohort. Previous primary outcome measure: Adverse events (AEs), serious adverse events (SAEs), AEs leading to study treatment discontinuation measured using study records up to 13 weeks for SAD and up to 16 weeks for MAD | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/03/2024: 1. Part 1 and Part 2: Serum concentrations of IMVT-1402 measured using blood samples will be collected up to Day 85 for Part 1 and up to Week 16 for Part 2. Pharmacokinetics will be analyzed using non-compartmental analysis. 2. Part 1 and Part 2: Serum concentrations of PD parameters including Total Immunoglobulin (IgG), IgG1, IgG2, IgG3 and IgG4 up to Day 85 for Part 1 and up to Week 16 for Part 2. Pharmacodynamics will be analyzed using the Pharmacodynamic analysis set (PDAS). 3. Part 1 and Part 2: Number of participants with treatment-emergent positive anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs) up to Day 85 for Part 1 and up to Week 16 for Part 2. The ADA analysis will be based on the anti-drug antibodies analysis set (ADAAS). Previous secondary outcome measures as of 23/05/2023 to 11/03/2024: 1. Serum concentrations of IMVT-1402 measured using blood samples will be collected up to Day 85. Pharmacokinetics will be analyzed using non-compartmental analysis. 2. Serum concentrations of PD parameters including Total Immunoglobulin (IgG), IgG1, IgG2, IgG3 and IgG4 up to Day 85. Pharmacodynamics will be analyzed using the Pharmacodynamic analysis set (PDAS). 3. Number of participants with treatment-emergent positive anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs) up to Day 85. The ADA analysis will be based on the anti-drug antibodies analysis set (ADAAS). Previous secondary outcome measures: 1. Serum concentrations of IMVT-1402 up to Day 85 2. Serum concentrations of PD parameters including Total Immunoglobulin (IgG), IgG1, IgG2, IgG3 and IgG4 up to Day 85 3. Number of participants with treatment-emergent positive anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs) up to Day 85 | — |
Countries
New Zealand
Outcome results
None listed