Systemic Lupus ErythematosusPhase 1NCT03189017
A Phase I Study of ICP-022 in Healthy Subjects
A Phase 1 study testing ICP-022 in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Innocare Pharma Australia Pty Ltd at 1 site in Australia.
Trial summary
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration. 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
- Systemic Lupus Erythematosus, Rheumatoid Arthritis
- What is being tested?
- ICP-022
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Jul 2017to 30 Oct 2018
- 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
- Healthy male subjects age ≥18 and ≤55 years
- Body mass index ≥19 and ≤31 kg/m2, with minimum body weight of 50kg
- No clinically significant findings in the medical history and physical examination, especially with regard to the respiratory, heart, immune system, pancreas, liver, bile and gastrointestinal systems
- No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
- Subjects with a partner of child-bearing potential must be willing to use an approved form of contraception with a failure rate of <1%. Subjects must be willing to use a condom during sexual intercourse whether or not their partner is of child-bearing potential from screening until 90 days after their final study visit.
- Normal electrocardiogram (ECG), blood pressure, and heart rate, unless the investigator considers any abnormality to be clinically irrelevant
- Informed consent must be obtained in writing for all subjects personally at enrollment
Who cannot join
- Subjects with medically important events
- Having 1st degree relative with coronary heart disease at age <60
- Using of prescription drugs including but not limited to those known to interfere with metabolism of drugs within 30 days prior to dosing
- Exposure to any other medication, including over-the-counter medications, herbal remedies and vitamins for at least 14 days before randomization (except paracetamol
- Participation in another study with any investigational drug in 30 days or five half-lives (whichever is longer) preceding the study
- Current smoker, defined as more than 10 cigarettes or equivalent per day before the beginning of the study (participants currently smoking ≤10 cigarettes daily and able to completely stop smoking during the study from screening until follow-up are eligible)
Show all 24Show fewer
- Symptoms of a clinically significant illness in the 3 months before the study
- Presence or sequelae of respiratory, gastrointestinal, immune system, heart, liver or kidney disease, including asymptomatic unconjugated hyperbilirubinemia or asthma, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease
- Hemorrhoids or anal diseases with regular or recent presence of blood in feces
- History of immediate hypersensitivity to any medications or any food allergy, and acute phase of allergic rhinitis in the previous 2 weeks before randomization
- Blood or plasma donation of more than 500 mL during the previous 2 months before randomization and/or more than 50 mL in the 2 weeks prior to screening, or plan to donate any additional blood for 12 weeks after completing the study
- Subjects with a positive quantiFERON® test at screening or within 6 months prior to Day 1
- Positive test for human immunodeficiency virus (HIV)
- Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), unless caused by immunization
- Positive urine drug screen within 1 year before randomization
- Positive alcohol screen or active alcoholism
- Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study
- Subject has difficulty swallowing or is unable to swallow a tablet
- Unlikely to comply with the clinical study protocol eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
- Investigator, or any sub-investigator, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the protocol, or first degree relative thereof
- Subject requires anticoagulation treatment in the past 30 days
- Subject with anemia of any kind
- Subject with pancreatic abnormality of any kind, or elevated Lipase or Amylase >ULN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.
Read the detailed description
This is a single center, randomized, double-blind, dose escalation, placebo-controlled, first-in-humans phase 1 study to investigate the safety and tolerability of single and multiple escalating doses of ICP-022 in healthy volunteers. 40 healthy male participants (aged between 18 and 55 years of age inclusive) will be enrolled into Part 1 (single escalating dose administration) of this study, and additional 24 male subjects will be enrolled in Part 2 (multiple escalating dose administration). Part 1a consists of 5 cohorts of 8 participants each, while Part 2 includes 3 cohorts of 8 participants each.
Part 1a consists a treatment period with single oral dosing, and a safety follow-up to 7 days after dosing. Cohort 4 of Part 1a will return on Day 8 to repeat the study under fed condition in Part 1b.
Part 2 consists a treatment period with multiple dosing (once per day for 14 consecutive days), and a safety follow-up until 28 days after dosing. All subjects will receive either ICP-022 or placebo.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Being tested
- ICP-022, Placebos
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-022Drug
The drug product is a white, round, uncoated tablet.
PlacebosDrug
The placebo is a white, round, uncoated tablet.
| Study group | Role | What they receive |
|---|---|---|
| ICP-022 | Experimental | There are 5 cohorts in the Part 1 phase of the trial. Three quarters of subjects will be randomized to receive ICP-022 in a double-blind fashion. Five dose levels will be evaluated; dose escalation steps may be modified based on the safety from the previous dose. Cohort 4 will return on Day 8 and receive a single dose of ICP-022 under fed conditions.
In Part 2 phase of the trial,three quarters of subjects will be randomized to receive the ICP-022 in a double-blind fashion in 3 cohorts. ICP-022 will be administered once a day for 14 consecutive days. Receives: Drug: ICP-022 |
| Placebos | Placebo comparator | In part 1 phase of the trial, one quarter of subjects will be randomized to receive placebo in a double-blind fashion. Cohort 4 will return on Day 8 and receive a single dose of placebo under fed conditions.
In Part 2 phase of the trial,one quarter of subjects will be randomized to receive placebo in a double-blind fashion. Placebo will be administered once a day for 14 consecutive days. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events will be collected and the percentage of AE of different grades will be assessed.
Measured: up to 28 days
Secondary outcomes (6)
Maximum plasma drug concentrations (Cmax)
Individual plasma concentrations of ICP-022 will be measured and Cmax will be calculated with noncompartmental analysis using WinNonlin.
Measured: up to 16 days
Time of maximum plasma drug concentrations (Tmax)
Time of maximum plasma drug concentrations (Tmax) of ICP-022 will be recorded.
Measured: up to 16 days
Area under the concentration time curve up to the time "t" (AUC(0-t))
Area under the concentration time curve up to the time "t" (AUC(0-t)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Measured: up to 16 days
Area under the concentration time curve up to the last data point above LOQ (AUC(last))
Area under the concentration time curve up to the last data point above LOQ (AUC(last)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Measured: up to 16 days
Apparent half-life for designated elimination phases (t½)
Apparent half-life for designated elimination phases (t½) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Measured: up to 16 days
Percent target occupancy
PBMC from individual subject before and after dosing will be collected and the target occupancy will be determined by ELISA. The percent of target occupancy will be compared descritively.
Measured: up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start3 Jul 2017
- Primary completion5 Feb 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocare Pharma Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, Principal investigator, CMAX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189017
- Sponsor's protocol ID
- ICP-CL-001
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi J, Kim ST, Craft J. The pathogenesis of systemic lupus erythematosus-an update. Curr Opin Immunol. 2012 Dec;24(6):651-7. doi: 10.1016/j.coi.2012.10.004. Epub 2012 Nov 3.
PubMed 23131610Holroyd CR, Edwards CJ. The effects of hormone replacement therapy on autoimmune disease: rheumatoid arthritis and systemic lupus erythematosus. Climacteric. 2009 Oct;12(5):378-86. doi: 10.1080/13697130903025449.
PubMed 19591008Sanz I, Lee FE. B cells as therapeutic targets in SLE. Nat Rev Rheumatol. 2010 Jun;6(6):326-37. doi: 10.1038/nrrheum.2010.68.
PubMed 20520647Garcia A, De Sanctis JB. A Review of Clinical Trials of Belimumab in the Management of Systemic Lupus Erythematosus. Curr Pharm Des. 2016;22(41):6306-6312. doi: 10.2174/1381612822666160831103254.
PubMed 27587201Rovin BH, Furie R, Latinis K, Looney RJ, Fervenza FC, Sanchez-Guerrero J, Maciuca R, Zhang D, Garg JP, Brunetta P, Appel G; LUNAR Investigator Group. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. 2012 Apr;64(4):1215-26. doi: 10.1002/art.34359. Epub 2012 Jan 9.
PubMed 22231479Harandi A, Zaidi AS, Stocker AM, Laber DA. Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers. J Oncol. 2009;2009:567486. doi: 10.1155/2009/567486. Epub 2009 May 6.
PubMed 19424511
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose
- ClinicalTrials.gov ID
- NCT03189017
- Acronym / sponsor ID
- ICP-CL-001
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Innocare Pharma Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 16 Jun 2017 (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.
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.
Detailed description
This is a single center, randomized, double-blind, dose escalation, placebo-controlled, first-in-humans phase 1 study to investigate the safety and tolerability of single and multiple escalating doses of ICP-022 in healthy volunteers. 40 healthy male participants (aged between 18 and 55 years of age inclusive) will be enrolled into Part 1 (single escalating dose administration) of this study, and additional 24 male subjects will be enrolled in Part 2 (multiple escalating dose administration). Part 1a consists of 5 cohorts of 8 participants each, while Part 2 includes 3 cohorts of 8 participants each.
Part 1a consists a treatment period with single oral dosing, and a safety follow-up to 7 days after dosing. Cohort 4 of Part 1a will return on Day 8 to repeat the study under fed condition in Part 1b.
Part 2 consists a treatment period with multiple dosing (once per day for 14 consecutive days), and a safety follow-up until 28 days after dosing. All subjects will receive either ICP-022 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP-022 | Experimental | Drug: ICP-022There are 5 cohorts in the Part 1 phase of the trial. Three quarters of subjects will be randomized to receive ICP-022 in a double-blind fashion. Five dose levels will be evaluated; dose escalation steps may be modified based on the safety from the previous dose. Cohort 4 will return on Day 8 and receive a single dose of ICP-022 under fed conditions. In Part 2 phase of the trial,three quarters of subjects will be randomized to receive the ICP-022 in a double-blind fashion in 3 cohorts. ICP-022 will be administered once a day for 14 consecutive days. |
| Placebos | Placebo comparator | Drug: PlacebosIn part 1 phase of the trial, one quarter of subjects will be randomized to receive placebo in a double-blind fashion. Cohort 4 will return on Day 8 and receive a single dose of placebo under fed conditions. In Part 2 phase of the trial,one quarter of subjects will be randomized to receive placebo in a double-blind fashion. Placebo will be administered once a day for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subjects age ≥18 and ≤55 years
- Body mass index ≥19 and ≤31 kg/m2, with minimum body weight of 50kg
- No clinically significant findings in the medical history and physical examination, especially with regard to the respiratory, heart, immune system, pancreas, liver, bile and gastrointestinal systems
- No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
- Subjects with a partner of child-bearing potential must be willing to use an approved form of contraception with a failure rate of <1%. Subjects must be willing to use a condom during sexual intercourse whether or not their partner is of child-bearing potential from screening until 90 days after their final study visit.
Key exclusion criteria (24 listed)
- Subjects with medically important events
- Having 1st degree relative with coronary heart disease at age <60
- Using of prescription drugs including but not limited to those known to interfere with metabolism of drugs within 30 days prior to dosing
- Exposure to any other medication, including over-the-counter medications, herbal remedies and vitamins for at least 14 days before randomization (except paracetamol
- Participation in another study with any investigational drug in 30 days or five half-lives (whichever is longer) preceding the study
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 |
|---|---|---|
| ICP-022The drug product is a white, round, uncoated tablet. | Drug | ICP-022 |
| PlacebosThe placebo is a white, round, uncoated tablet. | Drug | Placebos |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: up to 28 days
Number of participants with treatment-related adverse events will be collected and the percentage of AE of different grades will be assessed.
6 secondary outcomes
Maximum plasma drug concentrations (Cmax)
Time frame: up to 16 days
Time of maximum plasma drug concentrations (Tmax)
Time frame: up to 16 days
Area under the concentration time curve up to the time "t" (AUC(0-t))
Time frame: up to 16 days
Area under the concentration time curve up to the last data point above LOQ (AUC(last))
Time frame: up to 16 days
Apparent half-life for designated elimination phases (t½)
Time frame: up to 16 days
Percent target occupancy
Time frame: up to 16 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 1 Aug 2019.
- Background: PubMed 23131610Choi J, Kim ST, Craft J. The pathogenesis of systemic lupus erythematosus-an update. Curr Opin Immunol. 2012 Dec;24(6):651-7. doi: 10.1016/j.coi.2012.10.004. Epub 2012 Nov 3.
- Background: PubMed 19591008Holroyd CR, Edwards CJ. The effects of hormone replacement therapy on autoimmune disease: rheumatoid arthritis and systemic lupus erythematosus. Climacteric. 2009 Oct;12(5):378-86. doi: 10.1080/13697130903025449.
- Background: PubMed 20520647Sanz I, Lee FE. B cells as therapeutic targets in SLE. Nat Rev Rheumatol. 2010 Jun;6(6):326-37. doi: 10.1038/nrrheum.2010.68.
- Background: PubMed 27587201Garcia A, De Sanctis JB. A Review of Clinical Trials of Belimumab in the Management of Systemic Lupus Erythematosus. Curr Pharm Des. 2016;22(41):6306-6312. doi: 10.2174/1381612822666160831103254.
- Background: PubMed 22231479Rovin BH, Furie R, Latinis K, Looney RJ, Fervenza FC, Sanchez-Guerrero J, Maciuca R, Zhang D, Garg JP, Brunetta P, Appel G; LUNAR Investigator Group. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. 2012 Apr;64(4):1215-26. doi: 10.1002/art.34359. Epub 2012 Jan 9.
- Background: PubMed 19424511Harandi A, Zaidi AS, Stocker AM, Laber DA. Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers. J Oncol. 2009;2009:567486. doi: 10.1155/2009/567486. Epub 2009 May 6.
- The Association of the British Pharmaceutical Industry (ABPI) represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sepehr Shakib principal investigator
CMAX
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 ICP-022 in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Innocare Pharma Australia Pty Ltd at 1 site in Australia.
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 7 inclusion and 24 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 1 Aug 2019. 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 Australia. 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 participants with treatment-related adverse events (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189017, which also lists 6 linked publications.
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 1 Aug 2019.