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NMDA receptor antagonist

(2R,6R)-Hydroxynorketamine hydrochloride for Depression

Phase 1
Waitlist Available
Led By Shruti Raja, MD, MHS
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days post dosing (sad), 11 days post dosing (mad)

Summary

This trial involves giving healthy volunteers a drug called (2R,6R)-Hydroxynorketamine hydrochloride. The goal is to monitor its safety and how it behaves in the body.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days post dosing (sad), 11 days post dosing (mad)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post dosing (sad), 11 days post dosing (mad) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability of (2R,6R)-Hydroxynorketamine
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, Area Under the Curve Concentration (AUC)
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, Half-life (t1/2)
+2 more
Secondary study objectives
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) relative spectral power
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) source localization
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) visual evoked time-locked data

Side effects data

From 2023 Phase 1 trial • 74 Patients • NCT04711005
17%
Tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAD Cohort 1
SAD Cohort 4
SAD Cohort 2
SAD Cohort 3
SAD Cohort 5
SAD Cohort 6
MAD Cohort 1
MAD Cohort 2
Placebo
CSF Capture Cohort 1

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohort 6Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes)
Group II: SAD Cohort 5Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes)
Group III: SAD Cohort 4Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes)
Group IV: SAD Cohort 3Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes)
Group V: SAD Cohort 2Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes)
Group VI: SAD Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes)
Group VII: MAD Cohort 2Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10
Group VIII: MAD Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10
Group IX: CSF Capture Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes)
Group X: PlaceboPlacebo Group1 Intervention
Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
(2R,6R)-Hydroxynorketamine hydrochloride
2021
Completed Phase 1
~80

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,918 Previous Clinical Trials
2,739,891 Total Patients Enrolled
702 Trials studying Depression
261,151 Patients Enrolled for Depression
Shruti Raja, MD, MHSPrincipal InvestigatorDuke University
~15 spots leftby Nov 2025
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