Healthy Volunteers
Conditions
Keywords
ORKA-001, Phase 1
Brief summary
This is a Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Healthy Participants.
Detailed description
This is a single center, phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study will enroll approximately 24 healthy volunteers. The ORKA-001 dose will be administered by a subcutaneous injection.
Interventions
DRUGORKA-001
ORKA-001 is supplied as sterile solution to be administered by SC injection
OTHERPlacebo
Placebo solution to be administered at a matching volume by SC injection
Sponsors
Oruka Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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 the confinement 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 of the study. 5. Willing to abstain from regular, continuous alcohol use or tobacco use as per protocol Key
Exclusion criteria
1. Any clinically significant medical condition or finding that, in the Investigator's opinion, is likely to unfavorably alter the risk of study participation, confound study 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 Investigator should not participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability] | Day 1 through one year | Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, and physical examinations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed serum concentration of ORKA-001 | Day 1 through one year | CMax of ORKA-001 |
| Time to CMax (TMax) of ORKA-001 | Day 1 through one year | TMax of ORKA-001 |
| Area Under the Serum Concentration-Time Curve (AUC) of ORKA-001 | Day 1 through one year | Area under the curve from the time of dosing to infinity (AUC0-inf) |
| Terminal elimination half-life (T1/2) | Day 1 through one year | T1/2 of ORKA-001 |
Countries
New Zealand
Contacts
STUDY_DIRECTORKyle Breitschwerdt
Oruka Therapeutics, Inc.
PRINCIPAL_INVESTIGATORPrincipal Investigator
Oruka Therapeutics Investigative Site
Outcome results
None listed