A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• Healthy males or females as determined by assessments at the Screening Visit.
• For Parts A, B, C, and E:
• a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening
• For Part D:
⁃ a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening
Locations
United States
Nebraska
Site #1
RECRUITING
Lincoln
New Jersey
Site #2
RECRUITING
Eatontown
New York
Site #3
RECRUITING
New York
Contact Information
Primary
ORX142 Centessa Program Lead
ORX142-0101study@centessa.com
617-468-5770
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 208
Treatments
Experimental: Part A: SAD Study in Healthy Adults
Experimental: Part B: Food-effect Evaluation in Healthy Adults
Experimental: Part C: MAD Study in Healthy Adults
Experimental: Part D: Evaluation of a Single Dose in Healthy Older Adults
Experimental: Part E: PoC Study in Acutely Sleep-deprived Healthy Adults
Related Therapeutic Areas
Sponsors
Leads: Centessa Pharmaceuticals (UK) Limited