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

NCT ID: NCT06944379

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2027-01-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

ORKA-002

Subcutaneous (SC) injection of ORKA-002

Group Type: EXPERIMENTAL

ORKA-002

Intervention Type: DRUG

ORKA-002 is supplied as sterile solution to be administered by SC injection

Placebo

Subcutaneous (SC) injection of placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo solution to be administered at a matching volume by SC injection

Interventions

ORKA-002

ORKA-002 is supplied as sterile solution to be administered by SC injection

Intervention Type: DRUG

Placebo

Placebo solution to be administered at a matching volume by SC injection

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oruka Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Breitschwerdt

Role: STUDY_DIRECTOR

Oruka Therapeutics, Inc.

Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Oruka Therapeutics Investigative Site

Locations

Oruka Therapeutics Investigative Site

Christchurch, New Zealand, New Zealand

Countries

New Zealand

Other Identifiers

ORKA-002-211

Identifier Type: -

Identifier Source: org_study_id