Healthy adults
Conditions
Interventions
GIA632 (i.v. or s.c.)
Placebo (i.v. or s.c.)
Sponsors
Sato Mika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Able to communicate well with the investigator, to understand and comply with the requirements of the study. - Healthy Japanese male and non-childbearing potential female participants 18 to 55 years of age, inclusive, and in good health as determined by past medical history, physical examination, vital signs, 12-lead Electrocardiogram (ECG), and laboratory tests at screening and baseline. - Weigh at least 40.0 kg (female) and 50.0 kg (male), up to a maximum of 120 kg, with a body mass index (BMI) within the range of 18.0- 29.9 kg/m2.
Exclusion criteria
Exclusion criteria: - Use of other investigational drugs at the time of screening, or within a period corresponding to less than 5 half-lives of the drug before screening, or within 30 days, whichever is longer. - Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or over the counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing. - History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. - Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs (treatment emergent), vital signs, ECG including QTcF, labs (hematology, clinical chemistry, coagulation, urinalysis) | — |
Contacts
Public ContactMika Sato
Novartis Pharma. K.K.
Outcome results
None listed