ORKA-001 in Healthy Volunteers

NCT06698939 | Completed Phase 1

• 1 other identifier: ORKA-001-111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Healthy Participants.

Conditions

Healthy Volunteers

Keywords

ORKA-001; Phase 1

Outcome Measures

Primary Outcomes (1)

• Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, and physical examinations.

  Day 1 through one year

Secondary Outcomes (4)

• Maximum observed serum concentration of ORKA-001

  Day 1 through one year

• Time to CMax (TMax) of ORKA-001

  Day 1 through one year

• Area Under the Serum Concentration-Time Curve (AUC) of ORKA-001

  Day 1 through one year

• Terminal elimination half-life (T1/2)

  Day 1 through one year

Study Arms (2)

ORKA-001

EXPERIMENTAL

Participants will receive subcutaneous injection of ORKA-001 at either 300 mg, 600 mg or 1200 mg.

Drug: ORKA-001

Placebo

PLACEBO COMPARATOR

Participants will receive a subcutaneous injection of placebo comparator.

Other: Placebo

Interventions

Placebo OTHER

Placebo solution to be administered at a matching volume by SC injection

Placebo

ORKA-001 DRUG

ORKA-001 is supplied as sterile solution to be administered by SC injection

ORKA-001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female participants
• to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2
• 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
• Using a highly effective method of contraception from admission through the end of the study.
• Willing to abstain from regular, continuous alcohol use or tobacco use as per protocol

You may not qualify if:

• 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
• History of severe allergic reactions or hypersensitivity
• Actively nursing or lactating
• Use of 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.

Sponsors & Collaborators

• Oruka Therapeutics, Inc.: lead

Study Sites (1)

Oruka Therapeutics Investigative Site

Christchurch, New Zealand

Location

Study Officials

• Kyle Breitschwerdt

  Oruka Therapeutics, Inc.

  STUDY DIRECTOR

• Principal Investigator

  Oruka Therapeutics Investigative Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 21, 2024
• Study Start: December 19, 2024
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

NZ (1)