Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine

A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration. Standard safety, pharmacokinetics (PK) and qEEG monitoring will be evaluated at all dose levels. Subsequently, a 3-cohort multiple ascending dose (MAD) study will be conducted. Doses will be administered on days 1, 4, 7, and 10. Standard safety parameters will be monitored, and PK will be evaluated at all dose levels.

Topic Depression
Compound Placebo Ketamine
Country United States of America
Visit trial

Trial Details



Trial Number

Sponsors & Collaborators

National Institute of Mental Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

Papers

A Phase 1 Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (2R,6R)-Hydroxynorketamine in Healthy Volunteers
This Phase I study evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of (2R,6R)-Hydroxynorketamine (RR-HNK) in healthy volunteers. It finds that RR-HNK has a minimal adverse event profile, no serious adverse events, and no anaesthetic or dissociative effects at all doses. The study also reports dose-proportional increases in PK parameters and promising PD outcomes, including gamma power increases in some participants and CNS exposure, supporting progression to Phase II.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.