- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949426
Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects
February 21, 2020 updated by: Kangpu Biopharmaceuticals, Ltd.
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- California Clinical Trials Medical Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria
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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KPG-818
Dose escalation
|
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.
Other Names:
|
No Intervention: Placebo
Matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 72 hrs post-dose
|
Number of Treatment-Emergent Adverse Events(TEAE)
|
Up to 72 hrs post-dose
|
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.
|
Up to 72 hrs post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood KPG-818 concentrations
Time Frame: Up to 72 hrs post-dose
|
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.
|
Up to 72 hrs post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Esther Yoon, MD, California Clinical Trials
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
September 29, 2019
Study Completion (Actual)
September 29, 2019
Study Registration Dates
First Submitted
May 8, 2019
First Submitted That Met QC Criteria
May 11, 2019
First Posted (Actual)
May 14, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KPG-818-SLE-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Systemic Lupus Erythematosus
-
SanofiCompletedCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusJapan
-
Kyowa Kirin Co., Ltd.RecruitingHealthy Volunteers | Systemic Lupus Erythematosus (SLE) | Cutaneous Lupus Erythematosus (CLE)Japan
-
Second Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China; Hunan Provincial Natural Science... and other collaboratorsActive, not recruitingCutaneous Lupus Erythematosus | Systemic Lupus Erythematosus RashChina
-
University Hospital, BrestRecruitingSystemic Lupus Erythematosus (SLE)France
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingSystemic Lupus Erythematosus, SLEChina
-
TJ Biopharma Co., Ltd.TerminatedSystemic Lupus Erythematosus (SLE)China
-
AstraZenecaActive, not recruitingActive Systemic Lupus ErythematosusThailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
-
Novartis PharmaceuticalsActive, not recruitingSystemic Lupus Erythematosus (SLE)Hungary, Spain, Germany, Israel, Thailand, France, Russian Federation, China, Japan, Taiwan, Korea, Republic of, Poland, Australia, Argentina, Czechia
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, France, Germany, Spain, Belgium, Russian Federation, Japan, Korea, Republic of, Argentina, Bulgaria, South Africa, Mexico, Canada, Brazil, Lithuania
-
Novartis PharmaceuticalsNot yet recruitingSystemic Lupus Erythematosus, SLE
Clinical Trials on KPG-818
-
Kangpu Biopharmaceuticals, Ltd.Active, not recruiting
-
Kangpu Biopharmaceuticals, Ltd.RecruitingHematological MalignanciesUnited States
-
TaiRx, Inc.CompletedCarcinoma | Advanced CancerTaiwan
-
M.D. Anderson Cancer CenterRecruitingMetastatic Melanoma | Clinical Stage IV Cutaneous Melanoma AJCC v8 | Pathologic Stage IV Cutaneous Melanoma AJCC v8United States
-
TaiRx, Inc.Active, not recruitingNeuroendocrine Tumors | Gastro-enteropancreatic Neuroendocrine Tumor | Neuroendocrine Carcinoma | Pancreatic Neuroendocrine Tumor | Lung Neuroendocrine NeoplasmTaiwan
-
TaiRx, Inc.CompletedCarcinoma | Advanced CancerUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)TerminatedMetastatic Pancreatic Carcinoma | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Recurrent Pancreatic Carcinoma | Locally Advanced Pancreatic CarcinomaUnited States
-
Corvus Pharmaceuticals, Inc.Active, not recruitingT-cell LymphomaUnited States, China, Australia, Korea, Republic of
-
Providence Health & ServicesRecruitingBRAF V600E Mutation Present | Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8 | Refractory Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | BRAF NP_004324.2:p.V600M | Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8 | Stage IVB Differentiated Thyroid Gland Carcinoma...United States
-
TaiRx, Inc.CompletedAdvanced CancerTaiwan