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First human trial for new drug ORKA-001 begins safety check

NCT ID NCT06698939

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a single injection of ORKA-001 in 24 healthy adults to see if it is safe and how the body processes it. Participants were randomly assigned to receive either the drug or a placebo. The main goal was to check for side effects and changes in vital signs, not 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-001
What could go wrong
This is an early, small study in healthy people, so it cannot show if ORKA-001 works for any disease. Side effects are possible but unknown.

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

24 people

The number who actually took part.

Started

Dec 2024

Finished

Mar 2026

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 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 defined in the protocol 4. Using a highly effective method of contraception from admission through the end of the study. 5. Willing to abstain from regular, continuous alcohol use or tobacco use as per protocol 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. History of severe allergic reactions or hypersensitivity 5. Actively nursing or lactating 6. Use of investigational drug therapy within 30 days prior to enrollment 7. 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

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