Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects

NCT03949426 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: KPG-818-SLE-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Treatment-Emergent Adverse Events [Safety and Tolerability]

  Number of Treatment-Emergent Adverse Events(TEAE)

  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.

  Up to 72 hrs post-dose

Secondary Outcomes (1)

• Blood KPG-818 concentrations

  Up to 72 hrs post-dose

Study Arms (2)

KPG-818

EXPERIMENTAL

Dose escalation

Drug: KPG-818

Placebo

NO INTERVENTION

Matching placebo

Interventions

KPG-818 DRUG

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.

Also known as: Matching placebo

KPG-818

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kangpu Biopharmaceuticals, Ltd.: lead

Study Sites (1)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Esther Yoon, MD

  California Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study is double-blind with regard to treatment (KPG-818 or placebo) at each dose level. Any clinical staff involved in the preparation or administration of the study intervention and who are unblinded will take no further part in the study. will remain blinded during the study conduct, unless otherwise required based on study findings. The pharmacokineticist will be unblinded to perform the final PK analyses after all participants have completed the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel and Sequential

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 14, 2019
• Study Start: May 1, 2019
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)