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The study consists of Part A, a randomized double-blind, single-ascending-dose study, and Part B, a randomized, double-blind, semi-sequential, escalating multiple-dose study, in healthy Japanese volunteers.
Part A includes the following two dose regimen groups:
Part B includes the following two dose regimen groups:
In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg single dose | Experimental | Subject will receive a single oral dose of ABX464 25 mg or its matching placebo |
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| 50 mg single dose | Experimental | Subject will receive a single oral dose of ABX464 50 mg or its matching placebo |
|
| 25 mg multiple dose | Experimental | Subject will receive a daily oral dose of ABX464 25 mg or its matching placebo for 28 days |
|
| 50 mg mulptiple dose | Experimental | Subject will receive a daily oral dose of ABX464 50 mg or its matching placebo for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 | Drug | Drug: ABX464 ABX464 is a new anti-inflammatory drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and SAEs | number of incidences of all adverse events (AEs) (causally related and non-related) and SAEs, will be described further categorized by severity | 6 weeks |
| incidence of treatment-emergent serious adverse events | number of incidences of treatment-emergent serious adverse events will be described | 6 weeks |
| incidence of treatment-emergent adverse events of special interest (AESIs). | number of incidences of treatment-emergent adverse events of special interest (AESIs) will be described. | 6 weeks |
| incidence of clinically significant laboratory abnormalities | number of incidences of clinically significant laboratory abnormalities will be described | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | Cmax of ABX464 will be derived from the plasma concentrations | 42 days |
| Area under the plasma concentration versus time curve (AUC) | AUC of ABX464 will be derived from the plasma concentrations |
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Inclusion Criteria:
Male Japanese volunteers.
20 to 45 years old.
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).
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).
Non-smokers at enrolment.
Subjects must understand, sign and date the written voluntary Informed Consent Form at the visit prior to any protocol-specific procedures.
Able and willing to comply with study visits and procedures as per protocol.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | Osaka | 532-0003 | Japan |
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| ID | Term |
|---|---|
| C000623073 | ABX464 |
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Part A: single-ascending-dose Part B: escalating multiple-dose
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| Placebo | Drug | Drug: Matching Placebo placebo matching with ABX464 |
|
| 42 days |
| Time to reach the maximum plasma concentration (tmax) | Tmax of ABX464 will be derived from the plasma concentrations | 42 days |
| miR124 level | concentration of miR124 expression will be measured in blood | 42 days |