Trial Outcomes & Findings for Study of NST-6179 in Healthy Subjects (NCT NCT05181085)

NCT ID: NCT05181085

Last Updated: 2024-06-24

Results Overview

Assessment of number of participants with AEs and SAEs to determine safety profile

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 70 participants
• Primary outcome timeframe: From screening to 14 days post final dose, up to 4 weeks.
• Results posted on: 2024-06-24

Participant Flow

Participant milestones

Measure	Single Dose Placebo Participants in Part A randomised to receive a single dose of placebo.	Single Dose 50 mg NST-6179 Participants in Part A randomised to receive a single dose of 50 mg NST-6179.	Single Dose 200 mg NST-6179 Participants in Part A randomised to receive a single dose of 200 mg NST-6179.	Single Dose 400 mg NST-6179 Participants in Part A randomised to receive a single dose of 400 mg NST-6179.	Single Dose 600 mg NST-6179 Participants in Part A randomised to receive a single dose of 600 mg NST-6179.	Single Dose 1000 mg NST-6179 Participants in Part A randomised to receive a single dose of 1000 mg NST-6179.	Multiple Dose Placebo Participants in Part B randomised to receive multiple doses of placebo.	Multiple Dose 200 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD).	Multiple Dose 400 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD).	Multiple Dose 1000 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD).
Overall Study STARTED	10	6	6	6	6	6	6	8	8	8
Overall Study COMPLETED	10	6	6	6	6	6	6	8	8	8
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of NST-6179 in Healthy Subjects

Baseline characteristics by cohort

Measure	Single Dose Placebo n=10 Participants Participants in Part A randomised to receive a single dose of placebo.	Single Dose 50 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 50 mg NST-6179.	Single Dose 200 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 200 mg NST-6179.	Single Dose 400 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 400 mg NST-6179.	Single Dose 600 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 600 mg NST-6179.	Single Dose 1000 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 1000 mg NST-6179.	Multiple Dose Placebo n=6 Participants Participants in Part B randomised to receive multiple doses of placebo.	Multiple Dose 200 mg NST-6179 (QD) n=8 Participants Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD).	Multiple Dose 400 mg NST-6179 (QD) n=8 Participants Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD).	Multiple Dose 1000 mg NST-6179 (QD) n=8 Participants Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD).	Total n=70 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	10 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	8 Participants n=24 Participants	8 Participants n=42 Participants	8 Participants n=42 Participants	70 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
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	0 Participants n=42 Participants	29 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	5 Participants n=24 Participants	4 Participants n=42 Participants	8 Participants n=42 Participants	41 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	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	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 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	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	7 Participants n=24 Participants	8 Participants n=42 Participants	7 Participants n=42 Participants	65 Participants n=42 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	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) 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 Kingdom	10 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	8 participants n=24 Participants	8 participants n=42 Participants	8 participants n=42 Participants	70 participants n=42 Participants

PRIMARY outcome

Timeframe: From screening to 14 days post final dose, up to 4 weeks.

Population: Safety population

Assessment of number of participants with AEs and SAEs to determine safety profile

Outcome measures

Measure	Single Dose Placebo n=10 Participants Participants in Part A randomised to receive a single dose of placebo.	Single Dose 50 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 50 mg NST-6179.	Single Dose 200 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 200 mg NST-6179.	Single Dose 400 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 400 mg NST-6179.	Single Dose 600 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 600 mg NST-6179.	Single Dose 1000 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 1000 mg NST-6179.	Multiple Dose Placebo n=6 Participants Participants in Part B randomised to receive multiple doses of placebo.	Multiple Dose 200 mg NST-6179 (QD) n=8 Participants Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD).	Multiple Dose 400 mg NST-6179 (QD) n=8 Participants Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD).	Multiple Dose 1000 mg NST-6179 (QD) n=8 Participants Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD).
Number of Participants With AEs and SAEs Following Administration of NST 6179 Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 Mild TEAEs	4 Participants	2 Participants	2 Participants	2 Participants	2 Participants	1 Participants	2 Participants	5 Participants	5 Participants	5 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 Mild treatment-related TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	4 Participants	4 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 Moderate treatment-related TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 Overall TEAEs	4 Participants	2 Participants	2 Participants	2 Participants	2 Participants	2 Participants	2 Participants	5 Participants	6 Participants	5 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 TEAEs leading to discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 TEAEs leading to death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 Moderate TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 Severe TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With AEs and SAEs Following Administration of NST 6179 Overall treatment-related TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 1

Population: PK population (all subjects who received NST-6179)

Measure of peak plasma concentration of NST 6179 after dose on Day 1

Outcome measures

Measure	Single Dose Placebo n=6 Participants Participants in Part A randomised to receive a single dose of placebo.	Single Dose 50 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 50 mg NST-6179.	Single Dose 200 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 200 mg NST-6179.	Single Dose 400 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 400 mg NST-6179.	Single Dose 600 mg NST-6179 n=6 Participants Participants in Part A randomised to receive a single dose of 600 mg NST-6179.	Single Dose 1000 mg NST-6179 n=8 Participants Participants in Part A randomised to receive a single dose of 1000 mg NST-6179.	Multiple Dose Placebo n=8 Participants Participants in Part B randomised to receive multiple doses of placebo.	Multiple Dose 200 mg NST-6179 (QD) n=8 Participants Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD).	Multiple Dose 400 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD).	Multiple Dose 1000 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD).
Peak Plasma Concentration (Cmax) of NST 6179	1100 ng/mL Geometric Coefficient of Variation 54.7	4880 ng/mL Geometric Coefficient of Variation 49.9	13200 ng/mL Geometric Coefficient of Variation 29.2	18300 ng/mL Geometric Coefficient of Variation 33.7	27200 ng/mL Geometric Coefficient of Variation 33.7	5690 ng/mL Geometric Coefficient of Variation 51.0	10500 ng/mL Geometric Coefficient of Variation 60.4	29100 ng/mL Geometric Coefficient of Variation 25.3	—	—

SECONDARY outcome

Timeframe: Day 14

Population: PK population (all subjects who received NST-6179)

Measure of peak plasma concentration of NST 6179 after dose on Day 14

Outcome measures

Measure	Single Dose Placebo n=8 Participants Participants in Part A randomised to receive a single dose of placebo.	Single Dose 50 mg NST-6179 n=8 Participants Participants in Part A randomised to receive a single dose of 50 mg NST-6179.	Single Dose 200 mg NST-6179 n=8 Participants Participants in Part A randomised to receive a single dose of 200 mg NST-6179.	Single Dose 400 mg NST-6179 Participants in Part A randomised to receive a single dose of 400 mg NST-6179.	Single Dose 600 mg NST-6179 Participants in Part A randomised to receive a single dose of 600 mg NST-6179.	Single Dose 1000 mg NST-6179 Participants in Part A randomised to receive a single dose of 1000 mg NST-6179.	Multiple Dose Placebo Participants in Part B randomised to receive multiple doses of placebo.	Multiple Dose 200 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD).	Multiple Dose 400 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD).	Multiple Dose 1000 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD).
Peak Plasma Concentration (Cmax) of NST 6179	6920 ng/mL Geometric Coefficient of Variation 28.0	10000 ng/mL Geometric Coefficient of Variation 34.9	31800 ng/mL Geometric Coefficient of Variation 39.9	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From screening to 14 days post final dose, up to 4 weeks.

assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected

Outcome measures

Outcome data not reported

Adverse Events

Single Dose Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Single Dose 50 mg NST-6179

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Single Dose 200 mg NST-6179

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Single Dose 400 mg NST-6179

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Single Dose 600 mg NST-6179

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Single Dose 1000 mg NST-6179

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Multiple Dose Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Multiple Dose 200 mg NST-6179 (QD)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Multiple Dose 400 mg NST-6179 (QD)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Multiple Dose 1000 mg NST-6179 (QD)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Dose Placebo n=10 participants at risk Participants in Part A randomised to receive a single dose of placebo.	Single Dose 50 mg NST-6179 n=6 participants at risk Participants in Part A randomised to receive a single dose of 50 mg NST-6179.	Single Dose 200 mg NST-6179 n=6 participants at risk Participants in Part A randomised to receive a single dose of 200 mg NST-6179.	Single Dose 400 mg NST-6179 n=6 participants at risk Participants in Part A randomised to receive a single dose of 400 mg NST-6179.	Single Dose 600 mg NST-6179 n=6 participants at risk Participants in Part A randomised to receive a single dose of 600 mg NST-6179.	Single Dose 1000 mg NST-6179 n=6 participants at risk Participants in Part A randomised to receive a single dose of 1000 mg NST-6179.	Multiple Dose Placebo n=6 participants at risk Participants in Part B randomised to receive multiple doses of placebo.	Multiple Dose 200 mg NST-6179 (QD) n=8 participants at risk Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD).	Multiple Dose 400 mg NST-6179 (QD) n=8 participants at risk Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD).	Multiple Dose 1000 mg NST-6179 (QD) n=8 participants at risk Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD).
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Nervous system disorders Dizziness	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Nervous system disorders Headache	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	33.3% 2/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	37.5% 3/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	62.5% 5/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	50.0% 4/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	25.0% 2/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Gastrointestinal disorders Nausea	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	25.0% 2/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Investigations SARS-CoV-2 test positive	10.0% 1/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Skin and subcutaneous tissue disorders Erythema	10.0% 1/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
General disorders Medical device site irritation	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Metabolism and nutrition disorders Decreased appetite	10.0% 1/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Nervous system disorders Cognitive disorder	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Nervous system disorders Lethargy	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Gastrointestinal disorders Constipation	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	25.0% 2/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Gastrointestinal disorders Dry mouth	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	25.0% 2/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
General disorders Catheter site swelling	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
General disorders Fatigue	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
General disorders Feeling of body temperature change	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Infections and infestations Nasopharyngitis	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Infections and infestations Vaulvovaginal candidiasis	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Metabolism and nutrition disorders Increased appetite	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	16.7% 1/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Psychiatric disorders Anxiety	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Psychiatric disorders Depressed mood	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Renal and urinary disorders Micturition frequency decreased	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/6 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	12.5% 1/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.	0.00% 0/8 • From screening to 14 days post final dose, up to 4 weeks. Reporting through regular investigator assessment.

Additional Information

Michelle Yokley

NorthSea Therapeutics BV

Phone: 31 035760 65 05

Email: info@northseatherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER