ORKA-001 in Healthy Volunteers

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: ORKA-001; Other: Placebo

• Registration Number: NCT06698939
• Lead Sponsor: Oruka Therapeutics, Inc.

Brief Summary

This is a Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-001 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, and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study will enroll approximately 24 healthy volunteers. The ORKA-001 dose will be administered by a subcutaneous injection.

Study Timeline

• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Study Start: 2024-12-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORKA-001	ORKA-001	Participants will receive subcutaneous injection of ORKA-001 at either 300 mg, 600 mg or 1200 mg.
Placebo	Placebo	Participants will receive a subcutaneous injection of placebo comparator.

Primary Outcome Measures

Name	Time	Method
Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]	Day 1 through one year	Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, and physical examinations.

Secondary Outcome Measures

Name	Time	Method
Maximum observed serum concentration of ORKA-001	Day 1 through one year	CMax of ORKA-001
Time to CMax (TMax) of ORKA-001	Day 1 through one year	TMax of ORKA-001
Area Under the Serum Concentration-Time Curve (AUC) of ORKA-001	Day 1 through one year	Area under the curve from the time of dosing to infinity (AUC0-inf)
Terminal elimination half-life (T1/2)	Day 1 through one year	T1/2 of ORKA-001

Trial Locations

Locations (1)

Oruka Therapeutics Investigative Site; 🇳🇿 Christchurch, New Zealand