Healthy VolunteersPhase 1NCT02243683
Safety Study of Immune System Modulator for Autoimmune Diseases
A Phase 1 study testing AX-024.HCl in people with Healthy Volunteers, run by Artax Biopharma Inc at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AX-024.HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Mar 2015
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]2.
- In good health as determined by medical history, physical examination, and clinical judgment of the investigator
- Subject with no history of autoimmune disease or cardiac disease
- Subjects must be available to complete the study (including follow-up visit).
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
- Subjects must provide written informed consent to participate in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 21 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Subjects who are smokers, or ex-smokers who have smoked in the last 3 months (determined by negative urine cotinine at screening visit).
- A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any drug.
- A clinically significant history of drug or alcohol abuse.
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Ltd
Merthyr Tydfil, Cardiff Road, CF48 4DR
About this study
Official title: A Randomized, Placebo Controlled, Double Blind, Dose Escalating, Crossover, Safety and Pharmacokinetic Study of AX-024.HCl in Healthy Male Subjects
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.
- Conditions
- Healthy Volunteers
- Being tested
- AX-024.HCl, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AX-024.HClDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo Receives: Drug: AX-024.HCl; Other: Placebo |
| Cohort B | Experimental | Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo Receives: Drug: AX-024.HCl; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Over a 72 hours period and 7 days after last dose
Secondary outcomes (1)
Area Under the Concentration-Time Curve
Measured: Over a 72 hours period post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionMar 2015
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artax Biopharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research, ORION Clinical Services, Packaging Coordinators Inc, Centro de Biología Molecular Severo Ochoa, Spain (CBMSO)
- Responsible party
- Sponsor
- Investigators
- Girish Sharma, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243683
- Sponsor's protocol ID
- AX-024-1.01
- Status last verified
- Oct 2015
- First submitted
- 16 Sep 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double Blind, Dose Escalating, Crossover, Safety and Pharmacokinetic Study of AX-024.HCl in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02243683
- Acronym / sponsor ID
- AX-024-1.01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Artax Biopharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research, ORION Clinical Services, Packaging Coordinators Inc, Centro de Biología Molecular Severo Ochoa, Spain (CBMSO)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Sep 2014 (estimated)
- 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 purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: AX-024.HCl, Other: PlaceboSingle ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo |
| Cohort B | Experimental | Drug: AX-024.HCl, Other: PlaceboSingle ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]2.
- In good health as determined by medical history, physical examination, and clinical judgment of the investigator
- Subject with no history of autoimmune disease or cardiac disease
- Subjects must be available to complete the study (including follow-up visit).
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
Key exclusion criteria (7 listed)
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 21 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Subjects who are smokers, or ex-smokers who have smoked in the last 3 months (determined by negative urine cotinine at screening visit).
- A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any drug.
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 |
|---|---|---|
| AX-024.HCl | Drug | Cohort A, Cohort B |
| Placebo | Other | Cohort A, Cohort B |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Over a 72 hours period and 7 days after last dose
1 secondary outcome
Area Under the Concentration-Time Curve
Time frame: Over a 72 hours period post dose
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 14 Oct 2015.
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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.
Girish Sharma, MBBS principal investigator
Simbec Research
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 AX-024.HCl in people with Healthy Volunteers, run by Artax Biopharma Inc at 1 site in United Kingdom.
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 6 inclusion and 7 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 14 Oct 2015. 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 United Kingdom. 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?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: Over a 72 hours period and 7 days after last dose). 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 14 Oct 2015.