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

NCT06944379 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-26

No results posted yet for this study

Summary

This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Oruka Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Kyle Breitschwerdt · Oruka Therapeutics, Inc.

  • Principal Investigator · Oruka Therapeutics Investigative Site

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944379 on ClinicalTrials.gov