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A Study of ORX489 in Healthy Adults

This study is looking for healthy adults, aged 18 to 60, to help understand a new medication called ORX489. Researchers want to learn about the safety of ORX489, how well people tolerate it, and how the body processes it after taking single and multiple doses. You would receive either ORX489 Tablets or Placebo Tablets (an inactive substance). The study aims to enroll 212 participants. The current recruitment status is unclear, but the goal is to characterize the safety and how the body handles ORX489.

Study design
This interventional study plans to enroll 212 healthy adult participants. It involves giving participants either ORX489 Tablets or Placebo Tablets.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment to a follow-up visit 7 days after discharge from the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07413666

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

Recruiting
PHASE1Ages 18–60InterventionalTreatment
Centessa Pharmaceuticals (UK) Limited
~212 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:ORX489 TabletsPlacebo Tablets

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A
Measured over From enrollment to the Follow-Up Visit 7 days post-discharge
+3 more outcomes measured

Conditions

Healthy Adult Male and Female Volunteers

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Healthy Volunteer

Where it's being run

1 sites across 1 states
Nebraska1

Who to contact

ORX489 Centessa Program Lead ORX489 Centessa Program Lead
[email protected]
617-468-5770
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part AFrom enrollment to the Follow-Up Visit 7 days post-discharge

    Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in healthy adult participants.

  • Part BFrom enrollment to the Follow-Up Visit 7 days post-discharge]

    Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in the fasted and fed states

  • Part CFrom enrollment to the Follow-Up Visit 7 days post-discharge]

    Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral multiple ascending doses of ORX489 in healthy adult participants

  • Part D:From enrollment to the Follow-Up Visit 7 days post-discharge

    Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single oral doses of ORX489 in sleep-deprived healthy adult participants