ORKA-001 in Healthy Volunteers

Key Inclusion Criteria:

1. Healthy male or female participants

2. 18 to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2

3. Willing and able to remain at the study site unit for the duration of theconfinement period and return for the outpatient visit/s defined in the protocol

4. Using a highly effective method of contraception from admission through the end ofthe study.

5. Willing to abstain from regular, continuous alcohol use or tobacco use as perprotocol

Key Exclusion Criteria:

1. Any clinically significant medical condition or finding that, in the Investigator'sopinion, is likely to unfavorably alter the risk of study participation, confoundstudy results, or interfere with the study conduct or compliance.

2. Known history of illicit drug use or drug abuse or harmful alcohol use

3. Known history of frequent tobacco or vaping use within 2 years prior to Screening

4. History of severe allergic reactions or hypersensitivity

5. Actively nursing or lactating

6. Use of investigational drug therapy within 30 days prior to enrollment

7. Unable to comply with study requirements or in the opinion of the Investigatorshould not participate in this study.