ORKA-001 in Healthy Volunteers (ORKA-001-111)

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

This is a Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Healthy Participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ORKA-001; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand
    • Oruka Therapeutics Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ORKA-001; Participants will receive subcutaneous injection of ORKA-001 at either 300 mg, 600 mg or 1200 mg.	Drug: ORKA-001; ORKA-001 is supplied as sterile solution to be administered by SC injection
Placebo Comparator: Placebo; Participants will receive a subcutaneous injection of placebo comparator.	Other: Placebo; Placebo solution to be administered at a matching volume by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, and physical examinations.	Day 1 through one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed serum concentration of ORKA-001	CMax of ORKA-001	Day 1 through one year
Time to CMax (TMax) of ORKA-001	TMax of ORKA-001	Day 1 through one year
Area Under the Serum Concentration-Time Curve (AUC) of ORKA-001	Area under the curve from the time of dosing to infinity (AUC0-inf)	Day 1 through one year
Terminal elimination half-life (T1/2)	T1/2 of ORKA-001	Day 1 through one year

Collaborators and Investigators

• Sponsor: Oruka Therapeutics, Inc.
• Investigators: Study Director: Kyle Breitschwerdt, Oruka Therapeutics, Inc.; Principal Investigator: Principal Investigator, Oruka Therapeutics Investigative Site

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Actual): March 13, 2026
• Study Completion (Actual): March 13, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; ORKA-001
• Other Study ID Numbers: ORKA-001-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No