Healthy VolunteersPhase 1NCT06944379
ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose
A Phase 1 study testing ORKA-002 in people with Healthy Volunteers, run by Oruka Therapeutics, Inc. at 1 site in New Zealand.
Trial summary
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ORKA-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNew Zealand
- Study dates
- 19 May 2025to 20 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female participants
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Oruka Therapeutics Investigative Site
Christchurch, New Zealand
About this study
Official title: 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 is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants.
Read the 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
- Being tested
- ORKA-002, Placebo
- Keywords
- ORKA-002, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORKA-002Drug
ORKA-002 is supplied as sterile solution to be administered by SC injection
PlaceboOther
Placebo solution to be administered at a matching volume by SC injection
| Study group | Role | What they receive |
|---|---|---|
| ORKA-002 | Experimental | Subcutaneous (SC) injection of ORKA-002 Receives: Drug: ORKA-002 |
| Placebo | Placebo comparator | Subcutaneous (SC) injection of placebo comparator Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 through 1 year
Secondary outcomes (4)
Maximum observed serum concentration of ORKA-002
Cmax of ORKA-002
Measured: Day 1 through 1 year
Time to Cmax (Tmax) of ORKA-002
Tmax of ORKA-002
Measured: Day 1 through 1 year
Area under the serum concentration-time curve (AUC) of ORKA-002
Area under the curve from the time of dosing to infinity (AUC0-inf)
Measured: Day 1 through 1 year
Terminal elimination half-life (T1/2)
T1/2 of ORKA-002
Measured: Day 1 through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start19 May 2025
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oruka Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Breitschwerdt, Study director, Oruka Therapeutics, Inc.Principal Investigator, Principal investigator, Oruka Therapeutics Investigative Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944379
- Sponsor's protocol ID
- ORKA-002-211
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06944379
- Acronym / sponsor ID
- ORKA-002-211
- Conditions
- Healthy Volunteers
- Keywords
- ORKA-002, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oruka Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORKA-002 | Experimental | Drug: ORKA-002Subcutaneous (SC) injection of ORKA-002 |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous (SC) injection of placebo comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female participants
- 18 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORKA-002ORKA-002 is supplied as sterile solution to be administered by SC injection | Drug | ORKA-002 |
| PlaceboPlacebo solution to be administered at a matching volume by SC injection | Other | Placebo |
Primary outcome
Incidence of Treatment-emergent Adverse Events
Time frame: Day 1 through 1 year
Incidence of treatment-emergent adverse events and clinically significant changes from baseline in vital signs, electrocardiograms, and clinical laboratory parameters
4 secondary outcomes
Maximum observed serum concentration of ORKA-002
Time frame: Day 1 through 1 year
Time to Cmax (Tmax) of ORKA-002
Time frame: Day 1 through 1 year
Area under the serum concentration-time curve (AUC) of ORKA-002
Time frame: Day 1 through 1 year
Terminal elimination half-life (T1/2)
Time frame: Day 1 through 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Breitschwerdt study director
Oruka Therapeutics, Inc.
Principal Investigator principal investigator
Oruka Therapeutics Investigative Site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORKA-002 in people with Healthy Volunteers, run by Oruka Therapeutics, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Adverse Events (time frame: Day 1 through 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.