Safety and Pharmacokinetics Study in Healthy Japanese Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of ABX464 Capsules in Healthy Japanese Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032560
• Other study ID #: ABX464-921
• Status: Completed
• Phase: Phase 1
• Start date: September 27, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: January 2023
• Source: Abivax S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects).

Part B includes the following two dose regimen groups:

• 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days

• 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABX464
Drug: ABX464 ABX464 is a new anti-inflammatory drug
• Placebo
Drug: Matching Placebo placebo matching with ABX464

Locations

Country	Name	City	State
Japan	Medical Corporation Heishinkai OPHAC Hospital	Osaka-shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Abivax S.A.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	incidence of treatment-emergent serious adverse events	number of incidences of treatment-emergent serious adverse events will be described	6 weeks
Primary	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
Primary	incidence of clinically significant laboratory abnormalities	number of incidences of clinically significant laboratory abnormalities will be described	6 weeks
Secondary	Maximum Plasma Concentration [Cmax]	Cmax of ABX464 will be derived from the plasma concentrations	42 days
Secondary	Area under the plasma concentration versus time curve (AUC)	AUC of ABX464 will be derived from the plasma concentrations	42 days
Secondary	Time to reach the maximum plasma concentration (tmax)	Tmax of ABX464 will be derived from the plasma concentrations	42 days
Secondary	miR124 level	concentration of miR124 expression will be measured in blood	42 days