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New drug ORKA-002 tested in humans for the first time

NCT ID NCT06944379

Knowledge-focused Sponsor: Oruka Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 1 trial is the first time ORKA-002 is being tested in humans. It involves 24 healthy adults to check the drug's safety, tolerability, and how the body processes it. Participants receive a single injection of either ORKA-002 or a placebo. The study is not designed to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ORKA-002
What could go wrong
This is a very early Phase 1 trial with only 24 healthy people. It tests safety, not effectiveness, so it may not lead to any treatment.
Why investors are watching

Oruka Therapeutics is testing ORKA-002 in humans for the first time. This small company's value depends on whether the drug is safe and behaves predictably in healthy volunteers, so this early readout is a key checkpoint.

If it works: If ORKA-002 shows acceptable safety and clear drug levels in the blood, Oruka can move the drug into later trials. That progress could attract partners or funding for a company of this size.

If it fails: Phase 1 trials often fail because the drug causes unexpected side effects or does not behave as expected. A poor result or a delay could set Oruka back and raise doubts about the drug's future.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Oruka Therapeutics Investigative Site

    Christchurch, New Zealand, New Zealand

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