NCT06698939

ORKA-001 in Healthy Volunteers

Phase 1, First-in-human, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, of ORKA-001 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• 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-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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ORKA-001	ORKA-001 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: 2024-12-19
• Primary completion: 2026-03-13
• Completion: 2026-03-13
• First posted: 2024-11-21
• Last updated: 2026-04-01

Locations

1 site across 1 country: New Zealand