ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: ORKA-002; Other: Placebo

• Registration Number: NCT06944379
• Lead Sponsor: Oruka Therapeutics, Inc.

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 in healthy volunteers. The study will enroll approximately 24 healthy volunteers. The ORKA-002 dose will be administered by a subcutaneous injection.

Study Timeline

• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-23
• Study First Posted: 2025-04-25
• Status Verified: 2025-05
• Study Start: 2025-05-19
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 at Screening
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)/s defined in the protocol
4. Using two methods of contraception (one being highly effective) from admission through the end of the study

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. Unwilling to abstain from regular, continuous alcohol use or tobacco use as per protocol
5. History of severe allergic reactions or hypersensitivity
6. Actively nursing, lactating, pregnant, or plans to be pregnant
7. Use of any investigational drug therapy within 30 days prior to enrollment
8. Unable to comply with study requirements or in the opinion of the Investigator should not participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORKA-002	ORKA-002	Subcutaneous (SC) injection of ORKA-002
Placebo	Placebo	Subcutaneous (SC) injection of placebo comparator

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events	Day 1 through 1 year	Incidence of treatment-emergent adverse events and clinically significant changes from baseline in vital signs, electrocardiograms, and clinical laboratory parameters

Secondary Outcome Measures

Name	Time	Method
Maximum observed serum concentration of ORKA-002	Day 1 through 1 year	Cmax of ORKA-002
Time to Cmax (Tmax) of ORKA-002	Day 1 through 1 year	Tmax of ORKA-002
Area under the serum concentration-time curve (AUC) of ORKA-002	Day 1 through 1 year	Area under the curve from the time of dosing to infinity (AUC0-inf)
Terminal elimination half-life (T1/2)	Day 1 through 1 year	T1/2 of ORKA-002

Trial Locations

Locations (1)

Oruka Therapeutics Investigative Site; 🇳🇿 Christchurch, New Zealand