Systemic Lupus ErythematosusPhase 1NCT03949426
Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects
A Phase 1 study testing KPG-818 in people with Systemic Lupus Erythematosus, run by Kangpu Biopharmaceuticals, Ltd. at 1 site in United States.
Trial summary
This is a Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- KPG-818
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 29 Sep 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if all the following criteria apply:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
- Body mass index (BMI) within the range 19 to 30 kg/m2 (inclusive).
- Males and females of non-childbearing potential.
- A male participant must agree to use a highly effective contraception as detailed in Appendix 4 of this protocol during the intervention period and for at least 3 months after the dose(s) of study intervention and refrain from freezing or donating sperm during this period and for 3 months after dosing.
- A female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP) as defined in Appendix 4. Female participants must have been surgically sterilized (bilateral oophorectomy or bilateral salpingectomy at least 3 months before the start of the study and/or hysterectomy); have premature ovarian failure confirmed by a specialist gynecologist; be postmenopausal (defined as ≥ 50 years and naturally [spontaneously] amenorrheic (postmenopausal) for ≥ 12 months); or have XY genotype, Turner syndrome or uterine agenesis.
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Participant has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the Investigator.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator, and confirmed by a repeat measurement at the Screening Visit or at admission (Day -1).
- Any positive result at the Screening Visit for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
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- Abnormal vital signs, after 5 minutes supine rest, as judged by the Investigator to be clinically significant, and confirmed by a repeat measurement at the Screening Visit or at admission (Day -1).
- Any history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant, confirmed by a repeat measurement at the Screening Visit or at admission (Day-1).
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to KPG-818.
- Judgment by the Investigator that the participants should not participate in the study if they have any ongoing or recent (i.e., during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to administration of study intervention.
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to administration(s) of study intervention or longer if the medication has a long half-life.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives, whichever is longer, of the first administration of study intervention in this study.
- Known or suspected history of drug abuse as judged by the Investigator.
- Current smokers or past smokers who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to the Screening Visit.
- History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.
- Positive screen for drugs of abuse, alcohol or cotinine (nicotine) at the Screening Visit or admission to the Clinical Unit.
- Participants who consume greater than 500 mg of caffeine or xanthine-containing products per day (e.g., coffee, tea, soft drinks, energy drinks, chocolate,) or who refuse to abstain from caffeine-containing or xanthine-containing foods or beverages from 48 hours prior to admission (Day -1) until discharge from the clinical unit.
- Use of red wine, Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, or grapefruit hybrids from 7 days before the start of study intervention (Day 1) in each dosing session (as applicable) until collection of the final PK sample in each dosing session (as applicable).
- Use of alcohol within 72 hours of dosing (Day 1).
- Participants who are vegans or have medical dietary restrictions.
- Participants who cannot communicate reliably with the Investigator.
- Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship or committed to an institution by governmental or juridical order.
- Involvement of any Kangpu Biopharmaceuticals, Ltd. or study site employee or their close relatives.
- Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit and for at least 3 months after the dose(s) of study intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group
Glendale, California, 91206
About this study
Official title: A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818
This is a Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818. The study will assist in identifying appropriate, well tolerated doses that can be administered in subsequent studies in healthy participants and participants with systemic lupus erythematosus (SLE).
Read the detailed description
A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to active drug and 2 subjects randomized to placebo). Five dose levels (2, 5, 10, 20 and 30 mg) are planned to be evaluated.The study will be double blinded with regard to treatment (KPG-818 or placebo) at each dose level. KPG-818 and placebo will be matched for formulation, appearance and number of capsules. Safety assessments will be performed throughout the study including physical examinations, vital signs, clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events. Pharmacokinetic blood and urine samples will be collected up to 72 hours after dosing. A post-treatment follow-up visit will be performed within 10 days of the last dose of study treatment.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- KPG-818
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPG-818Drug
Also called Matching placebo
KPG-818 Capsules (1 mg, 5 mg and 20 mg) for oral administration is the drug substance powder filled in capsule (PIC) dosage form. KPG-818 Capsules and placebo capsules are packaged in HDPE bottle capped with HDPE cap.
| Study group | Role | What they receive |
|---|---|---|
| KPG-818 | Experimental | Dose escalation Receives: Drug: KPG-818 |
| Placebo | No intervention | Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Treatment-Emergent Adverse Events(TEAE)
Measured: Up to 72 hrs post-dose
Maximum Tolerated Dose [Safety and Tolerability]
If dose escalation is stopped based on available safety data, the current dose level will be considered as the Minimum intolerable dose (MID). The dose just below the MID will be regarded as the MTD. If the dose escalation is stopped due to reaching exposure limit without dose limiting safety findings, the MTD cannot be determined.
Measured: Up to 72 hrs post-dose
Secondary outcomes (1)
Blood KPG-818 concentrations
Blood samples for analysis of KPG-818 and KPG-818H will be collected at pre-dose (within 30 minutes) and 0.5, 1, 2, 4, 6, 10, 12 and 18 hours post-dose on day 1; 24 and 36 hours post-dose on day 2; 48 hours post-dose on day 3 and 72 hours post-dose on day 4.
Measured: Up to 72 hrs post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 May 2019
- Primary completion29 Sep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Parallel and Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangpu Biopharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Yoon, MD, Principal investigator, California Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949426
- Sponsor's protocol ID
- KPG-818-SLE-101
- Status last verified
- Feb 2020
- First submitted
- 8 May 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818
- ClinicalTrials.gov ID
- NCT03949426
- Acronym / sponsor ID
- KPG-818-SLE-101
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kangpu Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 14 May 2019 (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 Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818. The study will assist in identifying appropriate, well tolerated doses that can be administered in subsequent studies in healthy participants and participants with systemic lupus erythematosus (SLE).
Detailed description
A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to active drug and 2 subjects randomized to placebo). Five dose levels (2, 5, 10, 20 and 30 mg) are planned to be evaluated.The study will be double blinded with regard to treatment (KPG-818 or placebo) at each dose level. KPG-818 and placebo will be matched for formulation, appearance and number of capsules. Safety assessments will be performed throughout the study including physical examinations, vital signs, clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events. Pharmacokinetic blood and urine samples will be collected up to 72 hours after dosing. A post-treatment follow-up visit will be performed within 10 days of the last dose of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel and Sequential
| Arm | Type | Receives |
|---|---|---|
| KPG-818 | Experimental | Drug: KPG-818Dose escalation |
| Placebo | No intervention | –Matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants are eligible to be included in the study only if all the following criteria apply:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
- Body mass index (BMI) within the range 19 to 30 kg/m2 (inclusive).
- Males and females of non-childbearing potential.
Key exclusion criteria (25 listed)
- Participant has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the Investigator.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator, and confirmed by a repeat measurement at the Screening Visit or at admission (Day -1).
- Any positive result at the Screening Visit for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
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 |
|---|---|---|
| KPG-818Also: Matching placeboKPG-818 Capsules (1 mg, 5 mg and 20 mg) for oral administration is the drug substance powder filled in capsule (PIC) dosage form. KPG-818 Capsules and placebo capsules are packaged in HDPE bottle capped with HDPE cap. | Drug | KPG-818 |
Primary outcome
Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 72 hrs post-dose
Number of Treatment-Emergent Adverse Events(TEAE)
Maximum Tolerated Dose [Safety and Tolerability]
Time frame: Up to 72 hrs post-dose
If dose escalation is stopped based on available safety data, the current dose level will be considered as the Minimum intolerable dose (MID). The dose just below the MID will be regarded as the MTD. If the dose escalation is stopped due to reaching exposure limit without dose limiting safety findings, the MTD cannot be determined.
1 secondary outcome
Blood KPG-818 concentrations
Time frame: Up to 72 hrs 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 25 Feb 2020.
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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.
Esther Yoon, MD principal investigator
California Clinical Trials
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 KPG-818 in people with Systemic Lupus Erythematosus, run by Kangpu Biopharmaceuticals, Ltd. 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 8 inclusion and 25 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 25 Feb 2020. 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. 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?
Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 72 hrs post-dose). The study lists 2 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 25 Feb 2020.