Ulcerative colitis
Conditions
Interventions
Part A
Part A includes the following two dose regimen groups:
- 25 mg dose regimen group: ABX464 25 mg or placebo
- 50 mg dose regimen group: ABX464 50 mg or placebo
In each dose regimen group, 12 su
Sponsors
Owada Yasuko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Male Japanese volunteers. 2.20 to 45 years old. 3.Considered by the Investigator, as healthy based on history, physical examination, and complete laboratory evaluation (laboratory parameters should be within normal ranges of the study center's laboratory or considered not clinically significant by the Investigator). 4.Vital signs (supine blood pressure, resting pulse rate, body temperature) should be within normal ranges and no deviation from standard 12-lead electrocardiogram (ECG) should be observed at screening. Body mass index (BMI) should be between 18 (inclusive) and 27 kg/m2 (inclusive). 5.Non-smokers at enrolment. 6.Subjects must understand, sign and date the written voluntary Informed Consent Form at the visit prior to any protocol-specific procedures. 7.Able and willing to comply with study visits and procedures as per protocol. 8.Males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after the last dose of study drug. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, and vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. In each case of delayed menstrual period (over 1 month between menstruations) in a female partner of a male subject, confirmation of absence of pregnancy of the partner is required. Male subjects must not be planning pregnancy, should use a condom and must not donate sperm during the study and for 6 months after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1.Acute disease state (e.g., nausea, vomiting, diarrhea, or fever within a week) or chronic infectious disease (positive results for hepatitis B surface antigen [HBsAg], hepatitis C virus antibody, human immunodeficiency virus antigen/antibody, tuberculosis determined by QuantiFERON-TB Gold Plus test). Subjects who have positive hepatitis B core antibody [HBcAb] can be enrolled but must have an undetectable hepatitis B virus [HBV] viral load (HBV DNA test). 2.Positive results for SARS-CoV-2 antigen determined by polymerase chain reaction method. 3.History of recent grade 3 or 4 opportunistic infection or underlying conditions that may predispose them to grade 3 or grade 4 infection. 4.History of cardiovascular, pulmonary, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematological, neurological, psychiatric, or systemic disease that could jeopardize the safety of the subject or the validity of the study results. 5.Illicit drug or alcohol abuse, or dependence within a year. 6.Blood donation within 3 months prior to screening. 7.Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer. 8.Use of any immunosuppressive drugs (except topical steroids) within 3 months prior to first dose. 9.Any history of hypersensitivity to drugs. 10.Any condition, which in the opinion of the Investigator, could compromise the subject's safety or adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A Primary safety endpoints: - The number of incidences of treatment-emergent serious adverse events (SAEs). - The number of incidences of treatment-emergent adverse events of special interest (AESIs). - The number of incidences of clinically significant laboratory abnormalities. - The number of incidences of all adverse events (AEs) (causally related and non-related) and SAEs, further categorized by severity. Pharmacokinetic endpoints: - Pre-dose plasma concentrations of ABX464 and ABX464-N-Glu at D1. - Post-dose plasma concentrations of ABX464 and ABX464-N-Glu at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 168 and 336 hours after treatment intake at D1. Part B Primary safety endpoints: - The number of incidences of treatment-emergent SAEs. - The number of incidences of treatment-emergent AESIs. - The number of incidences of adverse events leading to investigational product discontinuation. - The number of incidences of clinically significant laboratory abnormalities. - The number of incidences of all AE (causally related and non-related) and SAE, further categorized by severity. Pharmacokinetic endpoints: - Pre-dose plasma concentrations of ABX464 and ABX464-N-Glu at D1, D7, D14, D21, and D28. - Post-dose plasma concentrations of ABX464 and ABX464-N-Glu at 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours (D2 pre-dose) after treatment intake at D1. - Post-dose plasma concentrations of ABX464 and ABX464-N-Glu at 1, 2, 3, 4 hours after treatment intake at D7, D14, and D21. - Post-dose plasma concentrations of ABX464 and ABX464-N-Glu at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 168 and 336 hours after treatment intake at D28. Pharmacodynamic endpoints: - Levels of miR-124 expression in total blood (determined by quantitative polymerase chain reaction) pre-dose at D1, D7 and at D28. | — |
Contacts
Public ContactMasushi Shono
IQVIA Services Japan K.K.
Outcome results
None listed