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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03949426
• Date of registration: 08/05/2019
• Prospective Registration: No
• Primary sponsor: Kangpu Biopharmaceuticals, Ltd.
• Public title: Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects
• Scientific 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
• Date of first enrolment: May 1, 2019
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03949426
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Esther Yoon, MD
• Affiliation: California Clinical Trials

Key inclusion & exclusion criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria
apply:

1. Participant must be 18 to 55 years of age inclusive, at the time of signing the
informed consent.

2. Participants who are healthy as determined by medical evaluation including medical
history, physical examination, laboratory tests, and ECGs.

3. Body mass index (BMI) within the range 19 to 30 kg/m2 (inclusive).

4. Males and females of non-childbearing potential.

5. 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.

6. 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.

7. 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:

1. 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.

2. History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion of
drugs.

3. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks
of the first administration of study intervention.

4. 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).

5. Any positive result at the Screening Visit for serum hepatitis B surface antigen,
hepatitis C antibody and human immunodeficiency virus (HIV).

6. 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).

7. 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).

8. 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.

9. 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.

10. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks
prior to administration of study intervention.

11. 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.

12. 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.

13. Known or suspected history of drug abuse as judged by the Investigator.

14. 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.

15. History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.

16. Positive screen for drugs of abuse, alcohol or cotinine (nicotine) at the Screening
Visit or admission to the Clinical Unit.

17. 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.

18. 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).

19. Use of alcohol within 72 hours of dosing (Day 1).

20. Participants who are vegans or have medical dietary restrictions.

21. Participants who cannot communicate reliably with the Investigator.

22. Vulnerable participants, e.g., kept in detention, protected adults under guardianship,
trusteeship or committed to an institution by governmental or juridical order.

23. Involvement of any Kangpu Biopharmaceuticals, Ltd. or study site employee or their
close relatives.

24. 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: KPG-818

Primary Outcome(s)

Maximum Tolerated Dose [Safety and Tolerability] [Time Frame: Up to 72 hrs post-dose]

Treatment-Emergent Adverse Events [Safety and Tolerability] [Time Frame: Up to 72 hrs post-dose]

Secondary Outcome(s)

Blood KPG-818 concentrations [Time Frame: Up to 72 hrs post-dose]

Secondary ID(s)

KPG-818-SLE-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors