Healthy Adult Male and Female VolunteersSleepHealthy volunteersHealthmaxxingDrugPhase 1
What this study is
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
What's being tested
- ORX489 Tablets
Intervention · DRUG
ORX489 Tablets
- Placebo Tablets
Intervention · OTHER
Placebo Tablets
Study details
- Official title
- A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
- Conditions
- Healthy Adult Male and Female Volunteers
- Enrolling
- 212 people
- Starts
- 2026-02-25
- Est. completion
- 2027-06-30
- Design
- Double-blind, randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Healthy males or females as determined by assessments at the Screening Visit.
- For Parts A, B, C, and D:
- A. Participants must be at least 18 years of age and no more than 60 years of age at the Screening
You can't join if
- Presence of significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations.
- History of seizure disorder, any other condition that increases the risk of seizure 3. Has a clinically significant sleep disorder, including insomnia or sleep apnea.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openCelerion
Lincoln, Nebraska, United States
Recruiting
Study team
Sponsor
Centessa Pharmaceuticals (UK) Limited
Study ID Protocol ORX489-101
CONTACT
ORX489 Centessa Program Lead ORX489 Centessa Program Lead
CONTACT
Celerion Program Lead CA49982 United States, Nebraska [Recruiting]
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.