Healthy Volunteers

Primary objectives: The primary study objective is to determine the anticipated therapeutic dose (ATD) of LEAC-102 as single agent based on the dose limiting toxicity (DLT) observed in healthy volunteers. DLT is defined as any ≧ Grade 2 causally related to LEAC-102 administration adverse event as judged by investigator. DLT will be observed from start of LEAC-102 administration up to Final visit (planned consecutive 28 days of treatment period plus 7 days of safety follow-up). Secondary objectives: The secondary study objectives are to evaluate the safety and tolerability profiles of LEAC-102 alone in healthy volunteers.

LEAC-102

Extract of Taiwanofungus camphoratus

capsule

199.2 毫克Extract of Taiwanofungus camphoratus

1. Primary endpoint(s):
Determine the ATD* of LEAC-102
* Anticipated therapeutic dose (ATD) is defined as the highest dose level at which < 2 of 6 healthy
volunteers experienced a dose limiting toxicity (DLT).
2. Secondary endpoints:
1. Safety and tolerability: Incidence of adverse events (AEs) and serious adverse events
(SAEs)
2. Changes from baseline in vital signs, physical examination and laboratory
examination results
3. Exploratory endpoints:
Exploratory endpoints consisted of the following:
1. Change in lymphocyte activity (based on CD3, CD4, CD8, CD19 assessments) at
EOT visit compared to baseline
2. Change in serum adrenocorticotropin (ACTH), cortisol, progesterone, testosterone,
and estradiol (E2) at EOT visit compared to baseline
3. Findings in volume of adrenal gland at EOT visit compared to baseline

1. Inclusion criteria:
A healthy volunteer is eligible for the study if all of the following apply:
1. Adults aged between 20-40 years old (inclusive);
2. Physically and mentally healthy volunteers as confirmed by an interview, medical
A2TW0410_English synopsis v2.2_20MAR2018 based on protocol v2.2_20MAR2018 Page 3 of 7
history, clinical examination, chest X-rays, and electrocardiogram; volunteers with
non-clinically significant signs or symptoms may be eligible at investigator’s
discretion.
3. Body Mass Index (BMI) between 18.5 and 24, inclusive, (BMI will be calculated as
weight in kilogram [kg]/height in meters2
[m2
]);
4. Clinically normal hematology, biochemistry and urinalysis determinations based on
investigator’s discretion; volunteers with non-clinically significant signs or symptoms
may be eligible at investigator’s discretion;
5. Volunteer is willing and able to comply with study procedures and sign informed
consent prior to initiation of any study-mandated procedures.

2. Exclusion criteria:
Any volunteer meeting any of the exclusion criteria will be excluded from study
participation:
1. Volunteers who have a history or evidence of a medical condition that would expose
them to an undue risk of a significant adverse event or interfere with the assessments
of safety or pharmacodynamics variables during the course of the trial, including but
not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune,
neurological, musculoskeletal or hematological disease as determined by the clinical
judgment of the investigator;
2. Volunteer has received any investigational agent within 28 days prior to the first dose
of study drug;
3. Volunteers have taken or potentially take any prescription medication and/or overthe-counter medication from 1 week prior to the first dose of study drug to the end of
study period;
4. Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24
hours prior to the start of LEAC-102 administration;
5. Female volunteer of childbearing potential who:
- is lactating; or
- has positive pregnancy test; or
- refuses to adopt at least two forms of birth control (at least one of which must be a
barrier method) during the study.
Note:
Acceptable forms include:
1. Established use of oral, injected or implanted hormonal methods of contraception.
2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)
with spermicidal foam/gel/film/cream/suppository
6. Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of
study product
7. Any of hematologic clinically significant abnormality as judged by investigators
8. Any of the serum chemistry clinically significant abnormality as judged by
investigators
9. With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft
(CABG) surgery within the last 6 months prior to the screening visit
10. With history of cardiac failure (NYHA class 2 or above), unstable angina, or lifethreatening arrhythmia within the last 6 months prior to the screening visit
Note: NYHA = New York Heart Association
11. With blood pressures as systolic blood pressure <90mmHg or > 140mmHg or
diastolic blood pressure <50mmHg or > 90 mmHg
12. History of psychiatric disorder
13. History of left ventricular outflow obstruction, such as aortic stenosis and
hypertrophic cardiomyopathy
14. With a history of HIV infection or hepatitis B or C
Note: HIV = Human Immunodeficiency Virus
15. Diagnosed with cancer within 5 years prior to the screening visit except nonmetastatic basal or squamous cell carcinoma of the skin that has been treated
successfully or cancer in situ of the cervix uteri that has been handled by local
surgery.