NCT07439796RecruitingPhase 1
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORN252 in Healthy Participants
Orna Therapeutics, Inc.1 site in 1 country20 target enrollmentStarted: March 16, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants.
Study Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female participants who are healthy as determined by the Investigator based on review of medical history, physical examination, and laboratory tests
- •Participant is willing and able to comply with study visits and other protocol requirements
- •Other protocol specific inclusion criteria may apply
Exclusion Criteria
- •Clinically significant history or presence of organ dysfunction
- •Use of any investigational product within 3 months, or 5 half-lives, whichever longer
- •Other protocol specific exclusion criteria may apply
Arms & Interventions
Single Ascending Dose
Experimental
Ascending single dose of ORN252 on a specified day
Intervention: ORN252 (Biological)
Outcomes
Primary Outcomes
The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants.
Time Frame: 12 weeks
To evaluate the safety and tolerability of ORN252 administered to healthy adult participants.
Secondary Outcomes
- Pharmacokinetic (PK) parameters of ORN252 components(29 days)
- Pharmacodynamic (PD) effects of of ORN252(12 weeks)
- Immunogenicity of ORN252(12 weeks)
Investigators
Study Sites (1)
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