ORKA-001 in Healthy Volunteers (ORKA-001-111)

Oruka Therapeutics, Inc.

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ORKA-001; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06698939

ORKA-001-111

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

ORKA-001

Experimental group

Description:

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

Treatment:

Drug: ORKA-001

Placebo

Placebo Comparator group

Description:

Participants will receive a subcutaneous injection of placebo comparator.

Treatment:

Other: Placebo