Trial Outcomes & Findings for Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine (NCT NCT04711005)

NCT ID: NCT04711005

Last Updated: 2024-06-06

Results Overview

Investigational product-related adverse events and serious adverse events

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

74 participants

Primary outcome timeframe

8 days post dosing (SAD)

Results posted on

2024-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	SAD Cohort 1 (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	Placebo Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes). Placebo: Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period.	CSF Capture Cohort 1 (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Overall Study STARTED	6	6	6	6	6	6	6	9	19	4
Overall Study COMPLETED	6	6	6	6	6	6	6	6	18	4
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	SAD Cohort 1 (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	Placebo Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes). Placebo: Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period.	CSF Capture Cohort 1 (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	1	0	0
Overall Study Physician Decision	0	0	0	0	0	0	0	2	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 n=6 Participants (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 n=9 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	Placebo n=19 Participants Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes). Placebo: Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period.	CSF Capture Cohort 1 n=4 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	9 Participants n=24 Participants	19 Participants n=42 Participants	4 Participants n=42 Participants	74 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Continuous	36.2 years STANDARD_DEVIATION 12.48 • n=5 Participants	43.0 years STANDARD_DEVIATION 16.58 • n=7 Participants	32.5 years STANDARD_DEVIATION 6.50 • n=5 Participants	32.7 years STANDARD_DEVIATION 5.01 • n=4 Participants	29.7 years STANDARD_DEVIATION 3.88 • n=21 Participants	32.0 years STANDARD_DEVIATION 6.96 • n=10 Participants	39.0 years STANDARD_DEVIATION 2.68 • n=115 Participants	36.7 years STANDARD_DEVIATION 13.28 • n=24 Participants	37.9 years STANDARD_DEVIATION 10.45 • n=42 Participants	37.3 years STANDARD_DEVIATION 13.28 • n=42 Participants	35.4 years STANDARD_DEVIATION 9.49 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=24 Participants	7 Participants n=42 Participants	2 Participants n=42 Participants	30 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	6 Participants n=24 Participants	12 Participants n=42 Participants	2 Participants n=42 Participants	44 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	9 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	9 Participants n=24 Participants	17 Participants n=42 Participants	4 Participants n=42 Participants	65 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	25 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	1 Participants n=115 Participants	5 Participants n=24 Participants	11 Participants n=42 Participants	2 Participants n=42 Participants	41 Participants n=42 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Region of Enrollment United States	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	9 Participants n=24 Participants	19 Participants n=42 Participants	4 Participants n=42 Participants	74 Participants n=42 Participants

PRIMARY outcome

Timeframe: 8 days post dosing (SAD)

Population: Does not include the CSF cohorts as those were exploratory.

Investigational product-related adverse events and serious adverse events

Outcome measures

Outcome measures
Measure	SAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 n=6 Participants (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability of (2R,6R)-Hydroxynorketamine	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	—	—

PRIMARY outcome

Timeframe: 19 days post dosing (MAD)

Investigational product-related adverse events and serious adverse events

Outcome measures

Outcome measures
Measure	SAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability of (2R,6R)-Hydroxynorketamine	1 Participants	2 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 days post dosing (SAD), 11 days post dosing (MAD)

Population: Does not include the CSF cohort as that was exploratory.

This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected.

Outcome measures

Outcome measures
Measure	SAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 n=6 Participants (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, Maximum Plasma Concentration (Cmax)	124 ng/mL Geometric Coefficient of Variation 31.1	304 ng/mL Geometric Coefficient of Variation 38.9	579 ng/mL Geometric Coefficient of Variation 21.3	1200 ng/mL Geometric Coefficient of Variation 26.0	2480 ng/mL Geometric Coefficient of Variation 30.3	4280 ng/mL Geometric Coefficient of Variation 16.6	1210 ng/mL Geometric Coefficient of Variation 20.8	2610 ng/mL Geometric Coefficient of Variation 13.4

PRIMARY outcome

Timeframe: 3 days post dosing (SAD), 11 days post dosing (MAD)

Population: Does not include the CSF cohort as that was exploratory.

This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected.

Outcome measures

Outcome measures
Measure	SAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 n=6 Participants (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, Time Taken to Reach Maximum Plasma Concentration (Tmax)	0.692 hours Interval 0.667 to 1.0	0.683 hours Interval 0.617 to 1.97	0.692 hours Interval 0.583 to 1.92	0.825 hours Interval 0.667 to 0.983	0.950 hours Interval 0.617 to 1.03	0.975 hours Interval 0.617 to 1.07	0.667 hours Interval 0.667 to 1.0	0.708 hours Interval 0.667 to 1.0

PRIMARY outcome

Timeframe: 3 days post dosing (SAD), 11 days post dosing (MAD)

This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected.

Outcome measures

Outcome measures
Measure	SAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 n=6 Participants (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, Area Under the Curve Concentration (AUC)	918 h*ng/mL Geometric Coefficient of Variation 22.9	2560 h*ng/mL Geometric Coefficient of Variation 23.5	5420 h*ng/mL Geometric Coefficient of Variation 15.2	11200 h*ng/mL Geometric Coefficient of Variation 14.5	19400 h*ng/mL Geometric Coefficient of Variation 15.1	38300 h*ng/mL Geometric Coefficient of Variation 23.7	9770 h*ng/mL Geometric Coefficient of Variation 10.6	18400 h*ng/mL Geometric Coefficient of Variation 15.1

PRIMARY outcome

Timeframe: 3 days post dosing (SAD), 11 days post dosing (MAD)

Population: Does not include the CSF cohort as that was exploratory.

This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected.

Outcome measures

Outcome measures
Measure	SAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 n=6 Participants (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 n=6 Participants (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 n=6 Participants (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 n=6 Participants (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, Half-life (t1/2)	7.10 hours Geometric Coefficient of Variation 14.9	7.41 hours Geometric Coefficient of Variation 16.2	7.92 hours Geometric Coefficient of Variation 8.0	8.18 hours Geometric Coefficient of Variation 19.8	7.84 hours Geometric Coefficient of Variation 7.9	6.67 hours Geometric Coefficient of Variation 14.9	8.01 hours Geometric Coefficient of Variation 14.7	7.60 hours Geometric Coefficient of Variation 23

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SAD Cohort 1 n=6 participants at risk (2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 2 n=6 participants at risk (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 3 n=6 participants at risk (2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 4 n=6 participants at risk (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 5 n=6 participants at risk (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	SAD Cohort 6 n=6 participants at risk (2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 1 n=6 participants at risk (2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	MAD Cohort 2 n=9 participants at risk (2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10 (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.	Placebo n=19 participants at risk Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes). Placebo: Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period.	CSF Capture Cohort 1 n=4 participants at risk (2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes) (2R,6R)-Hydroxynorketamine hydrochloride: (2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Nervous system disorders Headache	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	16.7% 1/6 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	16.7% 1/6 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	16.7% 1/6 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	10.5% 2/19 • Number of events 2 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Cardiac disorders Tachycardia	16.7% 1/6 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	5.3% 1/19 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Investigations Diastolic blood pressure increase	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	10.5% 2/19 • Number of events 2 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Metabolism and nutrition disorders Dehydratiuon	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	25.0% 1/4 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Injury, poisoning and procedural complications Procedure site pain	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	25.0% 1/4 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Injury, poisoning and procedural complications Puncture site pain	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	25.0% 1/4 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
General disorders Catheter site pain	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	25.0% 1/4 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	16.7% 1/6 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Musculoskeletal and connective tissue disorders Pain in fingers	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	11.1% 1/9 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Cardiac disorders Blood Pressure Systolic increased	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	11.1% 1/9 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Skin and subcutaneous tissue disorders Rash over arms	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	16.7% 1/6 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.
Eye disorders Visual Disturbance	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	16.7% 1/6 • Number of events 1 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/6 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/9 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/19 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.	0.00% 0/4 • Data were collected for the SAD arms through Day 8, MAD through Day 19, CSF through Day 8, and Placebo up to Day 19.

Additional Information

Michelle Mack

Duke University School of Medicine

Phone: 919 613 1107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place