PharmacokineticsPhase 1NCT05098080
Hutrukin to Analyze Safety and PK in Healthy Volunteers
A Phase 1 study testing Hutrukin in people with Pharmacokinetics, run by XBiotech, Inc. at 1 site in United States.
Trial summary
The study will be a Phase I, open label, safety and pharmacokinetics study of HutrukinTM in at least eight healthy subjects in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Hutrukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 5 Apr 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥18 and weight ≥40 kg.
- Adequate bone marrow function defined as:
- absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L)
- platelet count > 150,000/mm3
- hemoglobin of ≥ 10 g/dL
- Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
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- Adequate hepatic function defined as:
- serum albumin ≥ 3.0 g/dL
- total bilirubin ≤ 1.5 times lab ULN.
- alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
- aspartate aminotransferase (AST) ≤ 2.0 times lab ULN
- For female subjects of childbearing potential WOCBP, a negative pregnancy test at screening and the female subjects must agree to either abstain from sexual intercourse or use reliable, effective contraception such as hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, or use of a condom by their partner. Women of non-childbearing potential include those who cannot get pregnant medically, including post-menopausal women and those with a history of hysterectomy or surgical sterilization.
- Male participants must agree to abstain from sexual intercourse or use a reliable, effective contraceptive method, such as condoms, or have had a vasectomy. Alternatively, female partners of male subjects enrolled in the study must use reliable, effective contraception such as hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, or contraceptive sponge.
- Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.
Who cannot join
- Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Uncontrolled or significant cardiovascular disease, including:
- A myocardial infarction within the past 6 months.
- Uncontrolled angina within the past 3 months.
- Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Class II or higher.
- Uncontrolled hypertension (blood pressure >160 mm Hg systolic or >100 mm Hg diastolic).
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- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
- History of any clinically significant medical disorders the investigator decides should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Abnormal ECG with any clinically significant findings or with QTc >470 ms.
- Serious infection (example: sepsis, pneumonia, or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 3 months prior to the screening visit.
- Infectious disease:
- Positive HIV, RPR, Hepatitis B or C, TB (QuantiFERON-TB Gold (QFT)/ IGRA)
- History of immunodeficiency.
- Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
- Major surgery within 28 days prior to Day 0.
- History of progressive multifocal leukoencephalopathy (PML) or other demyelinating disease.
- History of malignancy before screening with the exception of squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix.
Trial locations and contacts
1 site in 1 country.
United States1 site
BioBehavioral Research of Austin, A Telemed2U Company
Austin, Texas, 78759
About this study
Official title: 2021-PT054: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin Via Intravenous Administration in Healthy Subjects.
The study will be a Phase I, open label, safety and pharmacokinetics study of HutrukinTM in at least eight healthy subjects in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg).
Read the detailed description
Study Title: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin via Intravenous Administration in Healthy Subjects
Sponsor: XBiotech USA, Inc.
Study Chair: Neha Reshamwala, MD
Number of Planned Subjects: 24 healthy subjects with 8 subjects in each of the dose cohorts of HutrukinTM.
Approximate Duration:
Approximately 38 days which includes a screening period of up to 10 days followed by one intravenous push of Hutrukin and then evaluation over 28 days. Blood will be sampled at various time points for blood chemistry, hematological assessment and Hutrukin serum/plasma concentrations. Safety and tolerability will be evaluated.
- Conditions
- Pharmacokinetics
- Being tested
- Hutrukin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HutrukinBiological
Hutrukin that binds the human cytokine IL-1α with high affinity and is an effective blocker of IL-1α biological activity. Hutrukin is a True Human™ therapeutic antibody. That is, the antibody was generated by a natural human immune response and was cloned directly from a human peripheral B lymphocyte. No in vitro affinity maturation or modifications have been made to improve its natural binding affinity. A true human antibody should be effectively non-immunogenic in humans and thus exhibit optimal activity and pharmacokinetics indistinguishable from native IgG1 immunoglobulin.
PlaceboBiological
Placebo control for Hutrukin IV push.
| Study group | Role | What they receive |
|---|---|---|
| Hutrukin | Active comparator | At least six healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered Hutrukin. Receives: Biological: Hutrukin |
| Placebo | Placebo comparator | At least two healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment related adverse events assessed according to CTCAE v5.0 of one single intravenous dose of HutrukinTM in healthy subjects at each dose level.
Participants will be monitored for acute reactions, blood chemistry and hematology immediately after dosing and at multiple time points up to 28 days. All adverse events will be documented at multiple time points and assessed in terms those possibly, probably and definitely related to test article according to CTCAE v5.0 criteria. Anti-drug antibodies (ADA) will also be evaluated.
Measured: 28 days
Secondary outcomes (4)
Maximum plasma concentration of test article
The maximum plasma concentration will be assessed using a proprietary immunoassay to detect circulating HutrukinTM.
Measured: 28 days
Plasma concentration at various time points including terminal concentration
Terminal plasma concentration will be assessed at 28 days.
Measured: 28 days
Half-life
Half-life will be assessed.
Measured: 28 days
Total exposure
Area under the curve will be determined based on measured plasma levels over 28 days.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start10 Apr 2023
- Primary completion24 Oct 2023
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Eight healthy subjects will be in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg). For each dose cohort, six subjects will be administered Hutrukin and two will be administered placebo and the study will not proceed to the next dose level unless the tested dose level has been deemed to have acceptable tolerability and safety. Subjects will undergo blood sampling at multiple time points up to 28 days. Subjects will also be evaluated for the development of anti-drug antibodies (ADA). Dose escalation will utilize a 6+2 design with sentinel dosing and doses will be explored in cohort of 8 subjects (6 active drug and 2 placebo). There are two sub-groups, the first is comprised of one subject receiving Hutrukin and one subject receiving placebo, the second sub-group is comprised of five subjects receiving active drug and one subject receiving placebo. A 24-hour observation window will be given before enrolling the subjects in the second sub-group.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- XBiotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neha Reshamwala, MD, Principal investigator, BioBehavioral Research of Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098080
- Sponsor's protocol ID
- 2021-PT054
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2021
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No It is not yet known if there will be a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2021-PT054: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin Via Intravenous Administration in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05098080
- Acronym / sponsor ID
- 2021-PT054
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- XBiotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 28 Oct 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 will be a Phase I, open label, safety and pharmacokinetics study of HutrukinTM in at least eight healthy subjects in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg).
Detailed description
Study Title: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin via Intravenous Administration in Healthy Subjects
Sponsor: XBiotech USA, Inc.
Study Chair: Neha Reshamwala, MD
Number of Planned Subjects: 24 healthy subjects with 8 subjects in each of the dose cohorts of HutrukinTM.
Approximate Duration:
Approximately 38 days which includes a screening period of up to 10 days followed by one intravenous push of Hutrukin and then evaluation over 28 days. Blood will be sampled at various time points for blood chemistry, hematological assessment and Hutrukin serum/plasma concentrations. Safety and tolerability will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eight healthy subjects will be in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg). For each dose cohort, six subjects will be administered Hutrukin and two will be administered placebo and the study will not proceed to the next dose level unless the tested dose level has been deemed to have acceptable tolerability and safety. Subjects will undergo blood sampling at multiple time points up to 28 days. Subjects will also be evaluated for the development of anti-drug antibodies (ADA). Dose escalation will utilize a 6+2 design with sentinel dosing and doses will be explored in cohort of 8 subjects (6 active drug and 2 placebo). There are two sub-groups, the first is comprised of one subject receiving Hutrukin and one subject receiving placebo, the second sub-group is comprised of five subjects receiving active drug and one subject receiving placebo. A 24-hour observation window will be given before enrolling the subjects in the second sub-group.
| Arm | Type | Receives |
|---|---|---|
| Hutrukin | Active comparator | Biological: HutrukinAt least six healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered Hutrukin. |
| Placebo | Placebo comparator | Biological: PlaceboAt least two healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age: ≥18 and weight ≥40 kg.
- Adequate bone marrow function defined as:
- Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
- Adequate hepatic function defined as:
- For female subjects of childbearing potential WOCBP, a negative pregnancy test at screening and the female subjects must agree to either abstain from sexual intercourse or use reliable, effective contraception such as hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, or use of a condom by their partner. Women of non-childbearing potential include those who cannot get pregnant medically, including post-menopausal women and those with a history of hysterectomy or surgical sterilization.
Key exclusion criteria (19 listed)
- Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Uncontrolled or significant cardiovascular disease, including:
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
- History of any clinically significant medical disorders the investigator decides should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
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 |
|---|---|---|
| HutrukinHutrukin that binds the human cytokine IL-1α with high affinity and is an effective blocker of IL-1α biological activity. Hutrukin is a True Human™ therapeutic antibody. That is, the antibody was generated by a natural human immune response and was cloned directly from a human peripheral B lymphocyte. No in vitro affinity maturation or modifications have been made to improve its natural binding affinity. A true human antibody should be effectively non-immunogenic in humans and thus exhibit optimal activity and pharmacokinetics indistinguishable from native IgG1 immunoglobulin. | Biological | Hutrukin |
| PlaceboPlacebo control for Hutrukin IV push. | Biological | Placebo |
Primary outcome
Number of subjects with treatment related adverse events assessed according to CTCAE v5.0 of one single intravenous dose of HutrukinTM in healthy subjects at each dose level.
Time frame: 28 days
Participants will be monitored for acute reactions, blood chemistry and hematology immediately after dosing and at multiple time points up to 28 days. All adverse events will be documented at multiple time points and assessed in terms those possibly, probably and definitely related to test article according to CTCAE v5.0 criteria. Anti-drug antibodies (ADA) will also be evaluated.
4 secondary outcomes
Maximum plasma concentration of test article
Time frame: 28 days
Plasma concentration at various time points including terminal concentration
Time frame: 28 days
Half-life
Time frame: 28 days
Total exposure
Time frame: 28 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 23 Jul 2024.
- Individual participant dataSharing planned: No. No It is not yet known if there will be a plan to make IPD available
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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.
Neha Reshamwala, MD principal investigator
BioBehavioral Research of Austin
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 Hutrukin in people with Pharmacokinetics, run by XBiotech, Inc. at 1 site in United States.
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 14 inclusion and 19 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 23 Jul 2024. 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 States. 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. Some participants in this study may receive a placebo. 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 subjects with treatment related adverse events assessed according to CTCAE v5.0 of one single intravenous dose of HutrukinTM in healthy subjects at each dose level. (time frame: 28 days). 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 23 Jul 2024.