Status:
ACTIVE_NOT_RECRUITING
ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose
Lead Sponsor:
Oruka Therapeutics, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 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, pharmacokinetics (PK) of ORKA-002...
Eligibility Criteria
Inclusion
- Key
- Healthy male or female participants
- 18 to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2 at Screening
- Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit(s)/s defined in the protocol
- Using two methods of contraception (one being highly effective) from admission through the end of the study
- Key
Exclusion
- 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
- Unwilling to abstain from regular, continuous alcohol use or tobacco use as per protocol
- History of severe allergic reactions or hypersensitivity
- Actively nursing, lactating, pregnant, or plans to be pregnant
- Use of any 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
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06944379
Start Date
May 19 2025
End Date
January 1 2027
Last Update
September 26 2025
Active Locations (1)
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1
Oruka Therapeutics Investigative Site
Christchurch, New Zealand, New Zealand