Ensayos clínicos

Inclusion Criteria

• Healthy Participants
  • Must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
  • Must have a body weight in the range of 50 to 90 kilogram (kg) inclusive, and have a body mass index (BMI) of 18 to 30 kilogram per square meters kg/m^2  inclusive, at screening
  • Must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
    • Must be recorded in the participant's source documents and initialed by the investigator
  • Must be healthy on the basis of clinical laboratory tests performed at screening
  • Females must not be of childbearing potential, such as
    • Postmenopausal
      • > 45 years of age with amenorrhea for at least 12 months 
      • Any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 international units per liters (IU/L) or mIU/mL)
    • Permanently sterilized 
      • Bilateral tubal occlusion which includes tubal ligation procedures as consistent with local regulations
      • Hysterectomy
      • Bilateral salpingectomy
      • Bilateral oophorectomy
    • Otherwise incapable of pregnancy
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 4 months (≥ 5 half-lives) after receiving last dose of study agent
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy
    • Must agree to use a barrier method of birth control , either
      • Condom with spermicidal foam/gel/film/cream/suppository 
      • Partner with occlusive cap, diaphragm or cervical/vault caps with spermicidal foam/gel/film/cream/suppository
  • All men must also not donate sperm during the study and for 4 months (≥ 5 half-lives) after receiving the last dose of study agent
• Participants with Systemic Lupus Erythematosus
  • Must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
  • Must have a body weight in the range of 40 to 100 kg inclusive
  • Must have a BMI of 18 to 30 kilograms per square meters (kg/m^2) inclusive at screening
  • Must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus

Exclusion Criteria

• Healthy Participants
  • Currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers significant, including but not limited to
    • Neuromuscular disorder
    • Hematological disease
    • Immune deficiency states
    • Respiratory disease
    • Cardiovascular disease (including poor peripheral venous access)
    • Hepatic or gastrointestinal (GI) disease
    • Neurological or psychiatric disease
    • Ophthalmological disorders
    • Neoplastic disease
    • Renal or urinary tract diseases
    • Dermatological disease
  • Careful consideration should be given to past or current signs and symptoms of severe, progressive, or uncontrolled
    • Hepatic disease
    • Hematological disease
    • Gastrointestinal disease
    • Endocrine disease
    • Pulmonary disease
    • Cardiac disease
    • Neurologic/ cerebral disease
    • Psychiatric disease
  • Has a condition that might confound assessments including major surgery, substance abuse or acute illness
  • Is a woman of childbearing potential, is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 4 months (≥5 half-lives) after the last dose of study agent
• Participants with Systemic Lupus Erythematosus 
  • History or suspected occurrence of drug-induced SLE
  • Has active Central nervous system (CNS) lupus or history of severe CNS lupus including but not limited to
    • Seizures
    • Psychosis
    • Transverse myelitis
    • CNS vasculitis
    • Optic neuritis
  • Currently has or has had a history of any clinically significant medical illness or medical disorder the investigator considers significant, including but not limited to
    • Neuromuscular disorder
    • Hematological disease
    • Immune deficiency states
    • Respiratory disease
    • Cardiovascular disease, including poor peripheral venous access
    • Hepatic or gastrointestinal (GI) disease
    • Neurological or psychiatric disease
    • Ophthalmological disorders
    • Neoplastic disease
    • Renal or urinary tract diseases
    • Dermatological disease
  • Careful consideration should be given to past or current signs and symptoms of severe, progressive, or uncontrolled
    • Hepatic Disease
    • Hematological Disease
    • Gastrointestinal Disease
    • Endocrine Disease
    • Pulmonary Disease
    • Cardiac Disease
    • Neurologic/ cerebral Disease
    • Psychiatric disease
  • Has had major surgery requiring general anesthesia within 4 months before screening, and will not have fully recovered from surgery
  • Has surgery planned within 4 weeks prior to study agent administration, or during the expected study participation time, or within 4 months (≥5 half-lives) after the last dose of study agent administration
  • Has laboratory findings or biopsy results consistent with severe lupus nephritis