Clinical trial NCT06944379: ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ORKA-002
Phase 1
Lead sponsor: Oruka Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events
timeFrame: Day 1 through 1 year
Secondary outcomes:
measure: Maximum observed serum concentration of ORKA-002
timeFrame: Day 1 through 1 year
measure: Time to Cmax (Tmax) of ORKA-002
timeFrame: Day 1 through 1 year
measure: Area under the serum concentration-time curve (AUC) of ORKA-002
timeFrame: Day 1 through 1 year
measure: Terminal elimination half-life (T1/2)
timeFrame: Day 1 through 1 year
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Oruka Therapeutics Investigative Site
Study officials:
affiliation: Oruka Therapeutics, Inc.
name: Kyle Breitschwerdt
role: STUDY_DIRECTOR
affiliation: Oruka Therapeutics Investigative Site
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: