clinical trial · NCT06944379
ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose
Healthy VolunteersORKA-002Placebo
brief summary
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants.
started
May 19, 2025
primary completion
Jan 1, 2027
completion
Jan 1, 2027
last updated
Sep 26, 2025
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.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol