Multiple Ascending Dose Safety Study of ShK-186 (Dalazatide) in Healthy Volunteers

The purpose of this study is to examine safety outcomes in healthy volunteers after systemic
administration of multiple ascending doses of dalazatide delivered via subcutaneous injection
twice per week for a total of 9 doses.

Inclusion Criteria:

1. healthy normal male and female subjects, ages 18 to 45, inclusive;

2. able to communicate and able to provide valid, written informed consent;

3. within the body mass index (BMI) range of approximately 18.0 to 30.0 kg/m2, inclusive;

4. minimum weight of 50 kg;

5. willingness to remain totally abstinent or use adequate contraception; e.g., 2 of the
following methods: hormonal contraceptive, intrauterine device, condom, diaphragm, and
spermicidal gel/foam) in order to prevent pregnancy from the screening visit until 60
days after the follow-up visit. For men, the donation of sperm during this period is
also prohibited.

Exclusion Criteria:

1. the presence of clinically significant medical history as determined by the
investigator.

2. the history of clinically significant cardiac abnormalities or presence of clinically
significant abnormality on 12-lead ECG.

3. the history of pre-existing paresthesia or neuropathy;

4. abnormalities on neurologic exam at screening or baseline

5. the history of any cancer requiring systemic chemotherapy or radiation; individuals
with a history of non-melanoma skin cancer, nonrecurring carcinoma in situ treated
with laser or cryotherapy or cervical cancer-in-situ, resected surgically with no
evidence of disease, may be accepted on a case by case basis at the discretion of the
Investigator;

6. the presence of acute infection or history of acute infection within 7 days prior to
receipt of the study drug; additionally, oral temperature may not exceed 37.4°C at
baseline;

7. the presence of clinically significant laboratory abnormalities (chemistry panel of 20
analytes [Chem-20; fasted 10-12 hours], complete blood count [CBC], and urinalysis
[UA]) as determined by the investigator;

8. positive urine drug screen for drugs of abuse (opiates, methadone, cocaine,
amphetamines, cannabinoids, barbiturates, benzodiazepines, cotinine, tricyclic
antidepressants and alcohol) at Screening or at Baseline.

9. typical intake of more than 7 units of alcohol per week (one unit of alcohol equals
approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)

10. a positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human
Immunodeficiency Virus (HIV) antibody test ;

11. a history of multiple drug allergies that are important in the view of the
Investigator;

12. any history of anaphylaxis or a history of allergy to a medication, diet, or
environmental exposure (including bee stings) that are important in the view of the
Investigator;

13. participation in another clinical trial with receipt of an investigational product
within 60 days of dose administration (or 5 half lives, whichever is longer);

14. recent (within 1 year of Screening) history of illicit drug use;

15. history of alcohol abuse that is important in the view of the Investigator

16. inadequate venous access that would interfere with obtaining blood samples;

17. use of prescription medications, over the counter products, herbal remedies and
nutritional supplements within 7 days of study drug administration and throughout the
study, or the anticipated need for prescription medications prior to Study Completion;

18. recipients of blood transfusion or transfusion of blood or plasma products within 60
days of study drug administration;

19. donation of blood > 500 mL within 2 months of study drug administration;

20. positive pregnancy test at screening or at baseline (female subjects only);

21. history within the past 3 months of eating disorders or other conditions which may
lead to suspicion about the participant's nutritional status;

22. inability or unwillingness to comply with study restrictions