Phase 1, First-in-human, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, of ORKA-001 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- ORKA-001
- Conditions
- Healthy Volunteers
- Sponsor
- Oruka Therapeutics, Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Status
- Active, Not Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female participants
- •18 to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2
- •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
- •Using a highly effective method of contraception from admission through the end of the study.
- •Willing to abstain from regular, continuous alcohol use or tobacco use as per protocol
Exclusion Criteria
- •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.
- •Known history of illicit drug use or drug abuse or harmful alcohol use
- •Known history of frequent tobacco or vaping use within 2 years prior to Screening
- •History of severe allergic reactions or hypersensitivity
- •Actively nursing or lactating
- •Use of investigational drug therapy within 30 days prior to enrollment
- •Unable to comply with study requirements or in the opinion of the Investigator should not participate in this study.
Arms & Interventions
ORKA-001
Participants will receive subcutaneous injection of ORKA-001 at either 300 mg, 600 mg or 1200 mg.
Intervention: ORKA-001
Placebo
Participants will receive a subcutaneous injection of placebo comparator.
Intervention: Placebo
Outcomes
Primary Outcomes
Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 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 Outcomes
- Maximum observed serum concentration of ORKA-001(Day 1 through one year)
- Time to CMax (TMax) of ORKA-001(Day 1 through one year)
- Area Under the Serum Concentration-Time Curve (AUC) of ORKA-001(Day 1 through one year)
- Terminal elimination half-life (T1/2)(Day 1 through one year)