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

NCT06944379 | Active Not Recruiting Phase 1

• 1 other identifier: ORKA-002-211
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants.

Conditions

Healthy Volunteers

Keywords

ORKA-002; Phase 1

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1 through 1 year

Secondary Outcomes (4)

• Maximum observed serum concentration of ORKA-002

  Day 1 through 1 year

• Time to Cmax (Tmax) of ORKA-002

  Day 1 through 1 year

• Area under the serum concentration-time curve (AUC) of ORKA-002

  Day 1 through 1 year

• Terminal elimination half-life (T1/2)

  Day 1 through 1 year

Study Arms (2)

ORKA-002

EXPERIMENTAL

Subcutaneous (SC) injection of ORKA-002

Drug: ORKA-002

Placebo

PLACEBO COMPARATOR

Subcutaneous (SC) injection of placebo comparator

Other: Placebo

Interventions

ORKA-002 DRUG

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

ORKA-002

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female participants
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oruka Therapeutics, Inc.: lead

Study Sites (1)

Oruka Therapeutics Investigative Site

Christchurch, New Zealand, New Zealand

Location

Study Officials

• Kyle Breitschwerdt

  Oruka Therapeutics, Inc.

  STUDY DIRECTOR

• Principal Investigator

  Oruka Therapeutics Investigative Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 25, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

NZ (1)