NCT06944379

ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Oruka Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ORKA-002	ORKA-002 is supplied as sterile solution to be administered by SC injection
OTHER	Placebo	Placebo solution to be administered at a matching volume by SC injection

Timeline

• Start date: 2025-05-19
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-04-25
• Last updated: 2025-09-26

Locations

1 site across 1 country: New Zealand