A Phase 1 interventional study of ORKA-002 and Placebo in Healthy Volunteers, sponsored by Oruka Therapeutics, Inc.. Active, not recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Oruka Therapeutics, Inc. · Phase 1, Interventional, and Other
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants.
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 in healthy volunteers. The study will enroll approximately 24 healthy volunteers. The ORKA-002 dose will be administered by a subcutaneous injection.
Oruka Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Subcutaneous (SC) injection of ORKA-002
Drug: ORKA-002
Subcutaneous (SC) injection of placebo comparator
Other: Placebo
ORKA-002 is supplied as sterile solution to be administered by SC injection
Placebo solution to be administered at a matching volume by SC injection
Incidence of Treatment-emergent Adverse Events
Incidence of treatment-emergent adverse events and clinically significant changes from baseline in vital signs, electrocardiograms, and clinical laboratory parameters
Time frame: Day 1 through 1 year
Maximum observed serum concentration of ORKA-002
Cmax of ORKA-002
Time frame: Day 1 through 1 year
Time to Cmax (Tmax) of ORKA-002
Tmax of ORKA-002
Time frame: Day 1 through 1 year
Area under the serum concentration-time curve (AUC) of ORKA-002
Area under the curve from the time of dosing to infinity (AUC0-inf)
Time frame: Day 1 through 1 year
Terminal elimination half-life (T1/2)
T1/2 of ORKA-002
Time frame: Day 1 through 1 year
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Oruka Therapeutics, Inc.