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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06698939




Registration number
NCT06698939
Ethics application status
Date submitted
13/11/2024
Date registered
21/11/2024
Date last updated
25/11/2024

Titles & IDs
Public title
ORKA-001 in Healthy Volunteers
Scientific title
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
Secondary ID [1] 0 0
ORKA-001-111
Universal Trial Number (UTN)
Trial acronym
ORKA-001-111
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ORKA-001
Other interventions - Placebo

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

Placebo comparator: Placebo - Participants will receive a subcutaneous injection of placebo comparator.


Treatment: Drugs: ORKA-001
ORKA-001 is supplied as sterile solution to be administered by SC injection

Other interventions: Placebo
Placebo solution to be administered at a matching volume by SC injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [1] 0 0
Day 1 through one year
Secondary outcome [1] 0 0
Maximum observed serum concentration of ORKA-001
Timepoint [1] 0 0
Day 1 through one year
Secondary outcome [2] 0 0
Time to CMax (TMax) of ORKA-001
Timepoint [2] 0 0
Day 1 through one year
Secondary outcome [3] 0 0
Area Under the Serum Concentration-Time Curve (AUC) of ORKA-001
Timepoint [3] 0 0
Day 1 through one year
Secondary outcome [4] 0 0
Terminal elimination half-life (T1/2)
Timepoint [4] 0 0
Day 1 through one year

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Oruka Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Healthy Participants.
Trial website
https://clinicaltrials.gov/study/NCT06698939
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kyle Breitschwerdt
Address 0 0
Oruka Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Oruka Clinical Trials Information
Address 0 0
Country 0 0
Phone 0 0
(781) 560-0299
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06698939