Healthy VolunteersPhase 1NCT05032560
Safety and Pharmacokinetics Study in Healthy Japanese Volunteers
A Phase 1 study testing ABX464 in people with Healthy Volunteers, run by Abivax S.A. at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABX464
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- 27 Sep 2021to 18 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
About this study
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.
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.
Read the detailed 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).
- Conditions
- Healthy Volunteers
- Being tested
- ABX464, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464Drug
Drug: ABX464 ABX464 is a new anti-inflammatory drug
PlaceboDrug
Drug: Matching Placebo placebo matching with ABX464
| Study group | Role | What they receive |
|---|---|---|
| 25 mg single dose | Experimental | Subject will receive a single oral dose of ABX464 25 mg or its matching placebo Receives: Drug: ABX464; Drug: Placebo |
| 50 mg single dose | Experimental | Subject will receive a single oral dose of ABX464 50 mg or its matching placebo Receives: 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 Receives: 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 Receives: Drug: ABX464; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
incidence of treatment-emergent serious adverse events
number of incidences of treatment-emergent serious adverse events will be described
Measured: 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.
Measured: 6 weeks
incidence of clinically significant laboratory abnormalities
number of incidences of clinically significant laboratory abnormalities will be described
Measured: 6 weeks
Secondary outcomes (4)
Maximum Plasma Concentration [Cmax]
Cmax of ABX464 will be derived from the plasma concentrations
Measured: 42 days
Area under the plasma concentration versus time curve (AUC)
AUC of ABX464 will be derived from the plasma concentrations
Measured: 42 days
Time to reach the maximum plasma concentration (tmax)
Tmax of ABX464 will be derived from the plasma concentrations
Measured: 42 days
miR124 level
concentration of miR124 expression will be measured in blood
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start27 Sep 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A: single-ascending-dose Part B: escalating multiple-dose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032560
- Sponsor's protocol ID
- ABX464-921
- Status last verified
- Jan 2023
- First submitted
- 30 Aug 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05032560
- Acronym / sponsor ID
- ABX464-921
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part A: single-ascending-dose Part B: escalating multiple-dose
| Arm | Type | Receives |
|---|---|---|
| 25 mg single dose | Experimental | Drug: ABX464, Drug: PlaceboSubject will receive a single oral dose of ABX464 25 mg or its matching placebo |
| 50 mg single dose | Experimental | Drug: ABX464, Drug: PlaceboSubject will receive a single oral dose of ABX464 50 mg or its matching placebo |
| 25 mg multiple dose | Experimental | Drug: ABX464, Drug: PlaceboSubject will receive a daily oral dose of ABX464 25 mg or its matching placebo for 28 days |
| 50 mg mulptiple dose | Experimental | Drug: ABX464, Drug: PlaceboSubject will receive a daily oral dose of ABX464 50 mg or its matching placebo for 28 days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX464Drug: ABX464 ABX464 is a new anti-inflammatory drug | Drug | 25 mg multiple dose, 25 mg single dose, 50 mg mulptiple dose, 50 mg single dose |
| PlaceboDrug: Matching Placebo placebo matching with ABX464 | Drug | 25 mg multiple dose, 25 mg single dose, 50 mg mulptiple dose, 50 mg single dose |
Primary outcome
Incidence of adverse events (AEs) and SAEs
Time frame: 6 weeks
number of incidences of all adverse events (AEs) (causally related and non-related) and SAEs, will be described further categorized by severity
incidence of treatment-emergent serious adverse events
Time frame: 6 weeks
number of incidences of treatment-emergent serious adverse events will be described
incidence of treatment-emergent adverse events of special interest (AESIs).
Time frame: 6 weeks
number of incidences of treatment-emergent adverse events of special interest (AESIs) will be described.
incidence of clinically significant laboratory abnormalities
Time frame: 6 weeks
number of incidences of clinically significant laboratory abnormalities will be described
4 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: 42 days
Area under the plasma concentration versus time curve (AUC)
Time frame: 42 days
Time to reach the maximum plasma concentration (tmax)
Time frame: 42 days
miR124 level
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABX464 in people with Healthy Volunteers, run by Abivax S.A. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and SAEs (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.