Safety, tolerability, pharmacokinetics, and pharmacodynamics of single/multiple doses of IMVT-1402 in healthy participants and participants with autoimmune diseases
- Conditions
- Healthy volunteers and adults with autoimmune diseasesMusculoskeletal Diseases
- Registration Number
- ISRCTN11659633
- Lead Sponsor
- Immunovant Sciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 168
Current participant inclusion criteria as of 11/03/2024:
Participants between the ages of 18 and 75 years old 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method