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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06944379

Enrollment

Registered

2025-04-25

Start date

2025-05-19

Completion date

2027-01-31

Last updated

2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

ORKA-002, Phase 1

Brief 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.

Interventions

DRUGORKA-002

ORKA-002 is supplied as sterile solution to be administered by SC injection

OTHERPlacebo

Placebo solution to be administered at a matching volume by SC injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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 at Screening 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)/s defined in the protocol 4. Using two methods of contraception (one being highly effective) from admission through the end of the study 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. Unwilling to abstain from regular, continuous alcohol use or tobacco use as per protocol 5. History of severe allergic reactions or hypersensitivity 6. Actively nursing, lactating, pregnant, or plans to be pregnant 7. Use of any investigational drug therapy within 30 days prior to enrollment 8. Unable to comply with study requirements or in the opinion of the Investigator should not participate in this study

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-emergent Adverse Events	Day 1 through 1 year	Incidence of treatment-emergent adverse events and clinically significant changes from baseline in vital signs, electrocardiograms, and clinical laboratory parameters

Secondary

Measure	Time frame	Description
Maximum observed serum concentration of ORKA-002	Day 1 through 1 year	Cmax of ORKA-002
Time to Cmax (Tmax) of ORKA-002	Day 1 through 1 year	Tmax of ORKA-002
Area under the serum concentration-time curve (AUC) of ORKA-002	Day 1 through 1 year	Area under the curve from the time of dosing to infinity (AUC0-inf)
Terminal elimination half-life (T1/2)	Day 1 through 1 year	T1/2 of ORKA-002

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026