Evaluating ORKA-002 in healthy volunteers after a single dose

Phase 1, First-in-human, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Healthy Participants

This study is testing a new drug called ORKA-002 in healthy volunteers to see how safe it is and how the body processes it after a single dose.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Oruka Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Christchurch)
• Trial ID: NCT06944379 on ClinicalTrials.gov

What this trial studies

This Phase 1 study aims to assess the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants. It is a single-center, double-blind, placebo-controlled, randomized trial involving approximately 24 healthy volunteers. Participants will receive a subcutaneous injection of ORKA-002 or a placebo, and their responses will be monitored throughout the study. The findings will help determine the appropriate dosing and safety profile of ORKA-002 for future studies.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 65 with a BMI between 18 and 32 kg/m2.

Not a fit: Patients with significant medical conditions, a history of substance abuse, or severe allergies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of ORKA-002, paving the way for its use in treating various conditions.

How similar studies have performed: Other Phase 1 studies evaluating similar first-in-human approaches have shown success in establishing safety and pharmacokinetics for new treatments.

Eligibility criteria

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 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

Where this trial is running

Christchurch

• Oruka Therapeutics Investigative Site — Christchurch, New Zealand (Recruiting)

Study contacts

• Principal investigator: Principal Investigator — Oruka Therapeutics Investigative Site
• Study coordinator: Oruka Clinical Trials Information

Conditions Healthy Volunteers; ORKA-002; Phase 1