| Eligibility |
Inclusion Criteria:
1. Ability to understand and provide written informed consent.
2. Body mass index (BMI) within the range of 18-32 (inclusive).
3. Healthy male and female volunteers =18 and =55 years old at Screening.
4. Able and willing to comply with the requirements of the study and complete the full
sequence of protocol related doses, procedures, and evaluations.
5. Willing to agree not to use alcohol or recreational drugs and willing to have drug
screening, prior to the first dose of KNX100 and if drug use is suspected while active
in the study.
6. Willing to agree not to smoke cigarettes or use tobacco based products prior to the
first dose of KNX100 and for the entire duration of the study.
7. Males who are sexually active must use a condom OR be abstinent OR have the same sex
partner OR be surgically sterile OR have partner who is of non-childbearing potential,
for at least 90 days after the last dose of investigational drug. If female partner is
a Woman of Child-Bearing Potential (WOCBP), the female partner must use highly
effective methods of contraception, defined as below:
- Hormonal methods of contraception including oral contraceptives containing
combined estrogen and progesterone, a vaginal ring, injectable and implantable
hormonal contraceptives, intrauterine hormone-releasing system (e.g., Mirena) and
progestogen-only hormonal contraception associated with inhibition of ovulation.
- Nonhormonal intrauterine device,
- Bilateral tubal occlusion.
Exclusion Criteria:
1. Clinically significant history or presence of significant cardiovascular, respiratory,
hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or
psychiatric disorder. Any surgical or medical history which may significantly alter
the absorption, metabolism, or elimination of drugs or constitute a risk when taking
the study intervention; or interfering with the interpretation of data (e.g., gastric
bypass, cyclical vomiting, etc.). This includes a history of lymphoma, leukemia, or
any malignancy within 5 years except for basal cell or squamous epithelial carcinomas
of the skin that have been resected with no evidence of metastatic disease for 3
years.
2. Subjects who have a sitting or semi-supine blood pressure at screening or Day-1, after
resting for at least 3 minutes of systolic blood pressure >140 or <100 mmHg, or
diastolic blood pressure >90 or <60 mmHg.
3. Subjects who have a sitting or semi-supine pulse rate at screening or Day-1, after
resting for at least 3 minutes, outside the range of <50 or >90 beats/minute
4. Subjects who donated blood or who had a comparable blood loss (approximately 500 mL)
during the last 30 days prior to start of this study and while on study.
5. Clinically significant findings on the screening, Day -1, or predose Day 1
electrocardiogram (ECG) or physical examination, including QTcF duration >450 ms for
males and >470 ms for females on ECG.
6. Thyroid function tests outside the normal reference ranges and deemed clinically
significant by the study PI (and upon repeat).
7. Safety laboratory tests that are outside the normal reference ranges and deemed
clinically significant by the study PI (and upon repeat).
8. Any history of meningitis, septicemia, or pneumonia.
9. Any history or family history (first or second degree relative) of seizure disorder,
febrile convulsions.
10. Any clinically significant medical history of closed head trauma.
11. Any history of anaphylaxis or other significant allergy.
12. Any current diagnosis or clinically significant medical history of psychiatric illness
as diagnosed and documented by a medical practitioner and as defined by the American
Psychiatric Association Diagnostic and statistical manual of mental disorders 5th
edition (DSM-5).
13. Subjects with a history of chronic alcohol (regular daily intake of more than three
standard drinks) or drug abuse within the last 6 months prior to first administration,
or evidence of such abuse as indicated by the laboratory profile conducted during the
screening examination.
14. Subjects who have received prescription drugs or over-the-counter (OTC) medication
including dietary supplements, COVID-19 vaccine, standard dose vitamins, or herbal
products within 14 days prior to the first administration (with the exception of the
oral contraceptive pill).
15. Subjects who received any treatment agents known to alter the major organs or systems
within 30 days prior to the first administration (e.g., diuretics, nephro- or liver
toxic medication, barbiturates, phenothiazines, cimetidine, more than 1.0 L of
caffeine-containing beverages per day, etc.).
16. Diagnosed infection of any kind, e.g., viral, bacterial, fungal, or mycobacterial
within 1 month prior to the first dose of KNX100 or current fever or clinical signs or
symptoms of infection at screening or Day -1.
17. Treatment with an unapproved investigational therapeutic agent within 30 days (or 5
half-lives for small molecule agents) prior to the first dose of KNX100.
18. Females who are pregnant (positive pregnancy test at screening or prior to first
dose), lactating or unable/unwilling to use defined methods of contraception
throughout the study.
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