Trial Outcomes & Findings for Multiple Ascending Dose Study of TMP-301 in Healthy Subjects (NCT NCT06025396)

NCT ID: NCT06025396

Last Updated: 2025-07-29

Results Overview

Occurence of Adverse Events, spontaneously reported and identified through clinical laboratory tests, vital sign measurements, ECG, physical exams and psychiatric assessments.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Within each cohort from screening to end of the follow up period up to 25 days
• Results posted on: 2025-07-29

Participant Flow

Participant milestones

Measure	Cohort 1 - Active TMP-301 50 mg BID Fasted	Cohort 2 - Active TMP-301 50 mg QD Fasted	Cohort 3 - Active TMP-301 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Overall Study STARTED	5	6	6	6	7
Overall Study COMPLETED	0	5	5	5	6
Overall Study NOT COMPLETED	5	1	1	1	1

Reasons for withdrawal

Measure	Cohort 1 - Active TMP-301 50 mg BID Fasted	Cohort 2 - Active TMP-301 50 mg QD Fasted	Cohort 3 - Active TMP-301 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Overall Study Protocol-Specified Withdrawal	5	0	0	1	1
Overall Study Withdrawal by Subject	0	1	1	0	0

Baseline Characteristics

Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

Baseline characteristics by cohort

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 Participants 25 mg QD Fed	Placebo n=7 Participants Placebo: Multiple ascending dose comparator	Total n=30 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 8.17 • n=5 Participants	47.8 years STANDARD_DEVIATION 9.91 • n=7 Participants	45.7 years STANDARD_DEVIATION 10.42 • n=5 Participants	32.0 years STANDARD_DEVIATION 7.18 • n=4 Participants	38.1 years STANDARD_DEVIATION 8.51 • n=21 Participants	40.1 years STANDARD_DEVIATION 10.21 • n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	25 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	26 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	1 Participants n=10 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=10 Participants
Race (NIH/OMB) More than one race	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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	7 participants n=21 Participants	30 participants n=10 Participants

PRIMARY outcome

Timeframe: Within each cohort from screening to end of the follow up period up to 25 days

Occurence of Adverse Events, spontaneously reported and identified through clinical laboratory tests, vital sign measurements, ECG, physical exams and psychiatric assessments.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 Participants 25 mg QD Fed	Placebo n=7 Participants Placebo: Multiple ascending dose comparator
Number of Treatment-Emergent Adverse Events (Safety and Tolerability)	34 Number of TEAEs	54 Number of TEAEs	51 Number of TEAEs	20 Number of TEAEs	6 Number of TEAEs

SECONDARY outcome

Timeframe: Day 1

Population: Cohort 1 was twice daily dosing (BID). All other cohorts were once daily dosing (QD)

0-12 hours post-dose on Day 1, twice daily dosing

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 50 mg QD Fasted	Cohort 3 - Active TMP-301 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
To Evaluate the Plasma Area Under the Curve (AUC) 0-12 Hours After First Dose of TMP-301	888 h*ng/mL Standard Deviation 607	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=6 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
To Evaluate the Plasma Area Under the Curve (AUC) 0-24 Hours After First Dose of TMP-301	1310 h*ng/mL Standard Deviation 848	1130 h*ng/mL Standard Deviation 345	489 h*ng/mL Standard Deviation 165	—	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 Participants 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Maximum Plasma Concentration (Cmax) of TMP-301	149 ng/mL Standard Deviation 86.5	224 ng/mL Standard Deviation 150	220 ng/mL Standard Deviation 93.9	97.5 ng/mL Standard Deviation 44.2	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 Participants 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Time to Maximum Plasma Concentration (Tmax) of TMP-301	2.80 h Standard Deviation 0.84	2.67 h Standard Deviation 1.04	3.01 h Standard Deviation 1.11	3.17 h Standard Deviation 0.76	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 Participants 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Plasma Concentration of TMP-301 at 12 Hours After First Dose (C12)	33.3 ng/mL Standard Deviation 32.5	34.4 ng/mL Standard Deviation 25.4	23.2 ng/mL Standard Deviation 7.82	9.92 ng/mL Standard Deviation 4.43	—

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 Participants 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Plasma Concentration of TMP-301 at 24 Hours After First Dose (C24)	9.61 ng/mL Standard Deviation 17.2	9.23 ng/mL Standard Deviation 6.91	5.92 ng/mL Standard Deviation 1.56	2.32 ng/mL Standard Deviation 2.54	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn after Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Maximum Plasma Concentration (Cmax) of TMP-301 at Steady State	464 ng/mL Standard Deviation 114	517 ng/mL Standard Deviation 125	220 ng/mL Standard Deviation 70.8	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn after Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Average Plasma Concentration of TMP-301 at 12 Hours After Last Dose (C12)	204 ng/mL Standard Deviation 50.3	193 ng/mL Standard Deviation 59.8	67.7 ng/mL Standard Deviation 21.0	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn after Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Time to Maximum Plasma Concentration (Tmax) of TMP-301 at Steady State	1.86 h Standard Deviation 0.77	2.41 h Standard Deviation 1.13	2.41 h Standard Deviation 1.15	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Minimum Drug Concentration (Cmin) of TMP-301 at Steady State	125 ng/mL Standard Deviation 37.3	114 ng/mL Standard Deviation 44.7	30.1 ng/mL Standard Deviation 21.4	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Area Under the Curve (Exposure) at Steady-state( AUC0_tau,ss), Over the Dosing Interval.	4910 h*ng/mL Standard Deviation 1210	4630 h*ng/mL Standard Deviation 1430	1630 h*ng/mL Standard Deviation 501	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Plasma Concentration of TMP-301 at 24 Hours After Last Dose at Steady State (C24, ss)	121 ng/mL Standard Deviation 27.9	120 ng/mL Standard Deviation 45.7	31.2 ng/mL Standard Deviation 20.6	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Terminal Half-life (T1/2) of TMP-301	174.92 h Standard Deviation 139.78	125.86 h Standard Deviation 66.25	279.53 h Standard Deviation 378.19	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn after Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Apparent Total Plasma Clearance of TMP-301 After Extravascular Administration (CL/F)	10.7 L/h Standard Deviation 2.46	11.8 L/h Standard Deviation 4.10	16.4 L/h Standard Deviation 4.07	—	—

SECONDARY outcome

Timeframe: Day 14

Population: Subjects in Cohort 1 were withdrawn after Day 8, therefore Day 14 pharmacokinetic parameters were not estimated for this cohort.

Outcome measures

Measure	Cohort 1 - Active TMP-301 n=5 Participants 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=5 Participants 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=5 Participants 50 mg QD Fed	Cohort 4 - Active TMP-301 25 mg QD Fed	Placebo Placebo: Multiple ascending dose comparator
Apparent Volume of Distribution of TMP-301 at Steady State (Vz/F)	2610 L Standard Deviation 1930	2390 L Standard Deviation 1980	5010 L Standard Deviation 5010	—	—

Adverse Events

Cohort 1 - Active TMP-301

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2 - Active TMP-301

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 3 - Active TMP-301

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 4 - Active TMP-301

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 - Active TMP-301 n=5 participants at risk 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 participants at risk 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 participants at risk 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 participants at risk 25 mg QD Fed	Placebo n=7 participants at risk Placebo: Multiple ascending dose comparator
Psychiatric disorders Worsening of psychotic disorder	20.0% 1/5 • Number of events 1 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days

Other adverse events

Measure	Cohort 1 - Active TMP-301 n=5 participants at risk 50 mg BID Fasted	Cohort 2 - Active TMP-301 n=6 participants at risk 50 mg QD Fasted	Cohort 3 - Active TMP-301 n=6 participants at risk 50 mg QD Fed	Cohort 4 - Active TMP-301 n=6 participants at risk 25 mg QD Fed	Placebo n=7 participants at risk Placebo: Multiple ascending dose comparator
Cardiac disorders Palpitations	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Ear and labyrinth disorders Tinnitus	0.00% 0/5 • 25 days	33.3% 2/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Ear and labyrinth disorders Vertigo	40.0% 2/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Eye disorders Asthenopia	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Ear and labyrinth disorders Diplopia	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Eye disorders Photophobia	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Eye disorders Rentinopathy solar	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Eye disorders Vision blurred	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Eye disorders Visual acuity reduced	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Gastrointestinal disorders Abdominal discomfort	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Gastrointestinal disorders Constipation	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	33.3% 2/6 • 25 days	0.00% 0/7 • 25 days
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Gastrointestinal disorders Dry mouth	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Gastrointestinal disorders Glossodynia	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Gastrointestinal disorders Paraesthesia oral	0.00% 0/5 • 25 days	50.0% 3/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
General disorders Feeling abnormal	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
General disorders Feeling hot	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
General disorders Feeling of relaxation	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
General disorders Medical device site reaction	0.00% 0/5 • 25 days	50.0% 3/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
General disorders Thirst	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Infections and infestations Tinea cruris	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Injury, poisoning and procedural complications Ankle fracture	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Investigations Alanine aminotransferase increased	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Investigations Aspartate aminotransferase increased	40.0% 2/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Investigations Blood creatine phosphokinase increased	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Investigations Blood pressure increased	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • 25 days	33.3% 2/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Balance disorder	20.0% 1/5 • 25 days	16.7% 1/6 • 25 days	33.3% 2/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Disturbance in attention	40.0% 2/5 • 25 days	50.0% 3/6 • 25 days	66.7% 4/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Dizziness	20.0% 1/5 • 25 days	16.7% 1/6 • 25 days	33.3% 2/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Dysgeusia	0.00% 0/5 • 25 days	33.3% 2/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Headache	40.0% 2/5 • 25 days	66.7% 4/6 • 25 days	50.0% 3/6 • 25 days	0.00% 0/6 • 25 days	14.3% 1/7 • 25 days
Nervous system disorders Lethargy	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Loss of proprioception	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Paraesthesia	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	33.3% 2/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Somnolence	0.00% 0/5 • 25 days	33.3% 2/6 • 25 days	50.0% 3/6 • 25 days	16.7% 1/6 • 25 days	14.3% 1/7 • 25 days
Nervous system disorders Tension headache	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Nervous system disorders Tremor	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Abnormal dreams	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Anxiety	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Change in sustained attention	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Depressed mood	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Derealisation	40.0% 2/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Euphoric mood	0.00% 0/5 • 25 days	50.0% 3/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Hypervigilance	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Illusion	0.00% 0/5 • 25 days	33.3% 2/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Insomnia	80.0% 4/5 • 25 days	33.3% 2/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Intentional self-injury	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Irritability	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Libido decreased	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Psychotic disorder due to a general medical condition	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Tearfulness	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Psychiatric disorders Time perception altered	20.0% 1/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/7 • 25 days
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Vascular disorders Hot flush	0.00% 0/5 • 25 days	0.00% 0/6 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Vascular disorders Peripheral coldness	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days
Eye disorders Ocular Dyscomfort	0.00% 0/5 • 25 days	16.7% 1/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/6 • 25 days	0.00% 0/7 • 25 days

Additional Information

Director, Clinical Operations

Tempero Bio

Phone: 510-250-4750

Email: TMP-301-HNV-101@Temperobio.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator/site may not disclose, present, disseminate or produce any publication that contains information regarding the Services, Deliverables, or Study Data without Sponsor's prior written consent.
• Publication restrictions are in place

Restriction type: OTHER