Safety and Pharmacokinetics Study in Healthy Japanese Volunteers

NCT05032560 | Completed Phase 1

• 1 other identifier: ABX464-921
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Maximum Plasma Concentration [Cmax]

  42 days

• Area under the plasma concentration versus time curve (AUC)

  42 days

• Time to reach the maximum plasma concentration (tmax)

  42 days

• miR124 level

  42 days

Study Arms (4)

25 mg single dose

EXPERIMENTAL

Subject will receive a single oral dose of ABX464 25 mg or its matching placebo

Drug: ABX464; Drug: Placebo

50 mg single dose

EXPERIMENTAL

Subject will receive a single oral dose of ABX464 50 mg or its matching placebo

Drug: ABX464; Drug: Placebo

25 mg multiple dose

EXPERIMENTAL

Subject will receive a daily oral dose of ABX464 25 mg or its matching placebo for 28 days

Drug: ABX464; Drug: Placebo

50 mg mulptiple dose

EXPERIMENTAL

Subject will receive a daily oral dose of ABX464 50 mg or its matching placebo for 28 days

Drug: ABX464; Drug: Placebo

Interventions

ABX464 DRUG

Drug: ABX464 ABX464 is a new anti-inflammatory drug

25 mg multiple dose; 25 mg single dose; 50 mg mulptiple dose; 50 mg single dose

Placebo DRUG

Drug: Matching Placebo placebo matching with ABX464

25 mg multiple dose; 25 mg single dose; 50 mg mulptiple dose; 50 mg single dose

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male Japanese volunteers.
• 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.

You may not qualify if:

• 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).
• Positive results for SARS-CoV-2 antigen determined by polymerase chain reaction method.
• History of recent grade 3 or 4 opportunistic infection or underlying conditions that may predispose them to grade 3 or grade 4 infection.
• 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.
• Illicit drug or alcohol abuse, or dependence within a year.
• Blood donation within 3 months prior to screening.
• Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
• Use of any immunosuppressive drugs (except topical steroids) within 3 months prior to first dose.
• Any history of hypersensitivity to drugs.
• Any condition, which in the opinion of the Investigator, could compromise the subject's safety or adherence to the study protocol

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

MeSH Terms

Interventions

ABX464

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: single-ascending-dose Part B: escalating multiple-dose

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 2, 2021
• Study Start: September 27, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)