Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD) (NCT NCT04855747)

Last Updated: 2026-07-10

Results Overview

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

236 participants

Primary outcome timeframe

Baseline and Day 28

Results posted on

2026-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	REL-1017 A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet
Overall Study STARTED	119	117
Overall Study COMPLETED	110	109
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	REL-1017 n=119 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo n=117 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet	Total n=236 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Age, Categorical Between 18 and 65 years	119 Participants n=9 Participants	117 Participants n=27 Participants	236 Participants n=267 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Sex: Female, Male Female	89 Participants n=9 Participants	84 Participants n=27 Participants	173 Participants n=267 Participants
Sex: Female, Male Male	30 Participants n=9 Participants	33 Participants n=27 Participants	63 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	1 Participants n=27 Participants	1 Participants n=267 Participants
Race (NIH/OMB) Asian	3 Participants n=9 Participants	4 Participants n=27 Participants	7 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	15 Participants n=9 Participants	12 Participants n=27 Participants	27 Participants n=267 Participants
Race (NIH/OMB) White	97 Participants n=9 Participants	97 Participants n=27 Participants	194 Participants n=267 Participants
Race (NIH/OMB) More than one race	4 Participants n=9 Participants	3 Participants n=27 Participants	7 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=9 Participants	33 Participants n=27 Participants	57 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=9 Participants	80 Participants n=27 Participants	173 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=9 Participants	4 Participants n=27 Participants	6 Participants n=267 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Outcome measures

Outcome measures
Measure	REL-1017 n=119 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo n=117 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet
Change From Baseline to Day 28 in MADRS Total Score	-14.81 Scores on a scale (MADRS10) Standard Error 1.00	-13.9 Scores on a scale (MADRS10) Standard Error 1.01

SECONDARY outcome

Timeframe: Day 7

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 7. Change was calculated as Day 7 score minus Baseline score.

Outcome measures

Outcome measures
Measure	REL-1017 n=119 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo n=117 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet
Change From Baseline to Day 7 in MADRS Total Score	-9.66 Scores on a scale (MADRS10) Standard Error 0.77	-7.02 Scores on a scale (MADRS10) Standard Error 0.78

SECONDARY outcome

Timeframe: Day 28

Clinical Global Impression-Severity (CGI-S) is a clinician-rated assessment of illness severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Lower scores indicate less severe illness and a better outcome, whereas higher scores indicate more severe illness and a worse outcome. The outcome measure reports the change in CGI-S score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score

Outcome measures

Outcome measures
Measure	REL-1017 n=119 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo n=117 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet
Change From Baseline to Day 28 in Clinical Global Impression-Severity (CGI-S) Score CGI-S Day 28	-1.36 Scores on a scale (CGI-S) Standard Error 0.11	-1.24 Scores on a scale (CGI-S) Standard Error 0.11
Change From Baseline to Day 28 in Clinical Global Impression-Severity (CGI-S) Score CGI-S Day 7	-0.74 Scores on a scale (CGI-S) Standard Error 0.08	-0.48 Scores on a scale (CGI-S) Standard Error 0.08

SECONDARY outcome

Timeframe: Day 28

Remission was defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score ≤10 at Day 28. The MADRS total score ranges from 0 to 60, with lower scores indicating less severe depressive symptoms and a better outcome.

Outcome measures

Outcome measures
Measure	REL-1017 n=101 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo n=98 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet
MADRS10 Remission Rate at Day 28	34 Participants	23 Participants

SECONDARY outcome

Timeframe: Day 28

Population: The number analyzed was different from the overall partecipants because it indicates the partecipants who actually had the assessment within the pertinent time point window.

Response was defined as a ≥50% reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS total score ranges from 0 to 60, with lower scores indicating less severe depressive symptoms and a better outcome.

Outcome measures

Outcome measures
Measure	REL-1017 n=113 Participants A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo n=110 Participants Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet
MADRS10 Response Rate at Day 28 MADRS10 Response Rate Day 28	51 Participants	45 Participants
MADRS10 Response Rate at Day 28 MADRS10 Response Rate Day 7	25 Participants	13 Participants

Adverse Events

REL-1017

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Scientific Officer

Levomecor Inc.

Phone: +16462843119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	REL-1017 n=119 participants at risk A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet	Placebo n=117 participants at risk Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet
Nervous system disorders Paraesthesia	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Tremor	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Hypersomnia	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Memory impairment	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Migraine	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Headache	4.2% 5/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	7.7% 9/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Dizziness	2.5% 3/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	3.4% 4/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Sonnolence	3.4% 4/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Tension headache	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	1.7% 2/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Nervous system disorders Brain fog	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Nausea	2.5% 3/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	4.3% 5/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Diarrhoea	2.5% 3/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	3.4% 4/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Constipation	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	2.6% 3/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Dry mouth	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	2.6% 3/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Vomiting	2.5% 3/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	1.7% 2/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Gastroesophageal	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Dyspepsia	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations COVID-19	1.7% 2/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	3.4% 4/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Upper respiratory tract infection	3.4% 4/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Urinary tract infection	1.7% 2/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	2.6% 3/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Nasopharygitis	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	1.7% 2/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Gastoenteritis	1.7% 2/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Sinusitis	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Gastoenteritis viral	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Infections and infestations Influenza	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Insomnia	1.7% 2/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	4.3% 5/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Abnormal dreams	1.7% 2/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	1.7% 2/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Anxiety	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	1.7% 2/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Depression	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Irritability	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Binge drinking	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Allucinathion, auditory	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.85% 1/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Panic attack	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Suicidal behaviour	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Psychiatric disorders Suicidal ideation	0.84% 1/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	0.00% 0/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
General disorders Fatigue	3.4% 4/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	2.6% 3/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
General disorders Pyrexia	0.00% 0/119 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.	1.7% 2/117 • TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42). A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.