RecruitingPhase 1NCT07413666

A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years

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

Enrollment

212 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

  • Healthy males or females as determined by assessments at the Screening Visit.
  • For Parts A, B, C, and D: Participants must be at least 18 years of age and no more than 60 years of age at the Screening

Exclusion Criteria3

  • 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
  • Has a clinically significant sleep disorder, including insomnia or sleep apnea

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Interventions

DRUGORX489 Tablets

ORX489 Tablets

OTHERPlacebo Tablets

Placebo Tablets


Locations(1)

Celerion

Lincoln, Nebraska, United States

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NCT07413666


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