A Study of ORN252 in Healthy Participants
ConditionHealthy Volunteers - Male and Female
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOrna Therapeutics, Inc.
About this trial
The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
ORN252
Biological/VaccineORN252 is a lipid nanoparticle encapsulating a circular RNA encoding an anti-CD19 CAR protein.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Single Ascending DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants.
To evaluate the safety and tolerability of ORN252 administered to healthy adult participants.
Time frame
12 weeksSecondary outcomes
1
Pharmacokinetic (PK) parameters of ORN252 components
Area under the concentration versus time curve from time zero to the time of the last quantifiable concentration \[AUClast\]
Time frame
29 days2
Pharmacokinetic (PK) parameters of ORN252 components
Maximum concentration \[Cmax\]
Time frame
29 days3
Pharmacokinetic (PK) parameters of ORN252 components
Time of maximum concentration \[Tmax\]
Time frame
29 days4
Pharmacokinetic (PK) parameters of ORN252 components
Terminal elimination half-life \[t1/2\]
Time frame
29 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov