Trial Outcomes & Findings for Assessment of KAN-101 in Celiac Disease (ACeD) (NCT NCT04248855)

NCT ID: NCT04248855

Last Updated: 2024-08-06

Results Overview

Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 41 participants
• Primary outcome timeframe: Up to 28 Days
• Results posted on: 2024-08-06

Participant Flow

Participant milestones

Measure	SAD 0.15mg/kg All enrolled patients received one dose of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.3mg/kg All enrolled patients received one dose of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.6mg/kg All enrolled patients received one dose of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.2mg/kg All enrolled patients received one dose of 1.2mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.5mg/kg All enrolled patients received one dose of 1.5mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.15mg/kg All randomized patients received 3 doses of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.3mg/kg All randomized patients received 3 doses of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.6mg/kg All randomized patients received 3 doses of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD Placebo All randomized patients received 3 doses of placebo Placebo: Intravenous (IV) infusion
Overall Study STARTED	4	3	3	3	1	6	7	8	6
Overall Study COMPLETED	4	3	3	3	1	6	6	7	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of KAN-101 in Celiac Disease (ACeD)

Baseline characteristics by cohort

Measure	SAD 0.15mg/kg n=4 Participants All enrolled patients will receive one dose of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.3mg/kg n=3 Participants All enrolled patients will receive one dose of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.6mg/kg n=3 Participants All enrolled patients will receive one dose of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.2mg/kg n=3 Participants All enrolled patients will receive one dose of 1.2mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.5mg/kg n=1 Participants All enrolled patients will receive one dose of 1.5mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.15mg/kg n=6 Participants All randomized patients will receive 3 doses of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.3mg/kg n=7 Participants All randomized patients will receive 3 doses of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.6mg/kg n=8 Participants All randomized patients will receive 3 doses of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD Placebo n=6 Participants All randomized patients will receive 3 doses of placebo Placebo: Intravenous (IV) infusion	Total n=41 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 19.05 • n=5 Participants	30.3 years STANDARD_DEVIATION 15.72 • n=7 Participants	35.3 years STANDARD_DEVIATION 9.29 • n=5 Participants	29.3 years STANDARD_DEVIATION 11.37 • n=4 Participants	46 years STANDARD_DEVIATION 0 • n=21 Participants	47.2 years STANDARD_DEVIATION 12.32 • n=10 Participants	40.7 years STANDARD_DEVIATION 10.69 • n=115 Participants	36.3 years STANDARD_DEVIATION 16.19 • n=6 Participants	30.3 years STANDARD_DEVIATION 10.88 • n=6 Participants	38 years STANDARD_DEVIATION 13.9 • n=64 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	5 Participants n=115 Participants	7 Participants n=6 Participants	3 Participants n=6 Participants	31 Participants n=64 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	10 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Asian	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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Black or African American	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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	7 Participants n=115 Participants	8 Participants n=6 Participants	6 Participants n=6 Participants	41 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 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=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	1 participants n=21 Participants	6 participants n=10 Participants	7 participants n=115 Participants	8 participants n=6 Participants	6 participants n=6 Participants	41 participants n=64 Participants

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All patients who received any amount of study drug with treatment group based on the dose level received.

Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

Outcome measures

Measure	SAD 0.15mg/kg n=4 Participants All enrolled patients received one dose of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.3mg/kg n=3 Participants All enrolled patients received one dose of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.6mg/kg n=3 Participants All enrolled patients received one dose of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.2mg/kg n=3 Participants All enrolled patients received one dose of 1.2mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.5mg/kg n=1 Participants All enrolled patients will receive one dose of 1.5mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.15mg/kg n=6 Participants All randomized patients received 3 doses of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.3mg/kg n=7 Participants All randomized patients received 3 doses of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.6mg/kg n=8 Participants All randomized patients received 3 doses of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD Placebo n=6 Participants All randomized patients received 3 doses of placebo Placebo: Intravenous (IV) infusion
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) TEAE	4 Participants	3 Participants	2 Participants	3 Participants	1 Participants	6 Participants	5 Participants	7 Participants	4 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Grade 3 or higher TEAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) no TEAE	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7

Population: All patients who received at least 1 dose of KAN-101 and have at least 1 drug concentration value. A patient may have been excluded from summary statistics due to insufficient data or failure to meet acceptability criteria

Geometric mean of maximum drug concentration (Cmax)

Outcome measures

Measure	SAD 0.15mg/kg n=4 Participants All enrolled patients received one dose of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.3mg/kg n=2 Participants All enrolled patients received one dose of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.6mg/kg n=2 Participants All enrolled patients received one dose of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.2mg/kg n=3 Participants All enrolled patients received one dose of 1.2mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.5mg/kg n=1 Participants All enrolled patients will receive one dose of 1.5mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.15mg/kg n=5 Participants All randomized patients received 3 doses of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.3mg/kg n=7 Participants All randomized patients received 3 doses of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.6mg/kg n=8 Participants All randomized patients received 3 doses of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD Placebo All randomized patients received 3 doses of placebo Placebo: Intravenous (IV) infusion
Cmax Day 1	839 ng/mL Standard Deviation 498	1796 ng/mL Standard Deviation 1443	10900 ng/mL Standard Deviation 1140	19470 ng/mL Standard Deviation 3336	22350 ng/mL	967 ng/mL Standard Deviation 917	2527 ng/mL Standard Deviation 1299	5753 ng/mL Standard Deviation 1623	—
Cmax Day 7	—	—	—	—	—	588 ng/mL Standard Deviation 375	2937 ng/mL Standard Deviation 1539	6609 ng/mL Standard Deviation 754.7	—

SECONDARY outcome

Timeframe: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7

Population: All patients who received at least 1 dose of KAN-101 and have at least 1 drug concentration value. A patient may have been excluded from summary statistics due to insufficient data or failure to meet acceptability criteria

Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)

Outcome measures

Measure	SAD 0.15mg/kg n=3 Participants All enrolled patients received one dose of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.3mg/kg n=2 Participants All enrolled patients received one dose of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.6mg/kg n=2 Participants All enrolled patients received one dose of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.2mg/kg n=3 Participants All enrolled patients received one dose of 1.2mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.5mg/kg n=1 Participants All enrolled patients will receive one dose of 1.5mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.15mg/kg n=5 Participants All randomized patients received 3 doses of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.3mg/kg n=7 Participants All randomized patients received 3 doses of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.6mg/kg n=8 Participants All randomized patients received 3 doses of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD Placebo All randomized patients received 3 doses of placebo Placebo: Intravenous (IV) infusion
AUC Last Day 1	366.8 h*ng/mL Standard Deviation 147.7	646.3 h*ng/mL Standard Deviation 526.7	5365 h*ng/mL Standard Deviation 62.85	13920 h*ng/mL Standard Deviation 3033	16340 h*ng/mL	322.5 h*ng/mL Standard Deviation 290.7	1180 h*ng/mL Standard Deviation 653.7	3462 h*ng/mL Standard Deviation 986.4	—
AUC Last Day 7	—	—	—	—	—	205 h*ng/mL Standard Deviation 152	1258 h*ng/mL Standard Deviation 751	3914 h*ng/mL Standard Deviation 760	—

Adverse Events

SAD 0.15mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

SAD 0.3mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

SAD 0.6mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SAD 1.2mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

SAD 1.5mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MAD 0.15mg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

MAD 0.3mg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MAD 0.6mg/kg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

MAD Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SAD 0.15mg/kg n=4 participants at risk All enrolled patients received one dose of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.3mg/kg n=3 participants at risk All enrolled patients received one dose of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 0.6mg/kg n=3 participants at risk All enrolled patients received one dose of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.2mg/kg n=3 participants at risk All enrolled patients received one dose of 1.2mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	SAD 1.5mg/kg n=1 participants at risk All enrolled patients received one dose of 1.5mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.15mg/kg n=6 participants at risk All randomized patients received 3 doses of 0.15mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.3mg/kg n=7 participants at risk All randomized patients received 3 doses of 0.3mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD 0.6mg/kg n=8 participants at risk All randomized patients received 3 doses of 0.6mg/kg KAN-101 KAN-101: Intravenous (IV) infusion	MAD Placebo n=6 participants at risk All randomized patients received 3 doses of placebo Placebo: Intravenous (IV) infusion
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	66.7% 2/3 • Number of events 2 • Up to 28 Days	66.7% 2/3 • Number of events 2 • Up to 28 Days	100.0% 1/1 • Number of events 1 • Up to 28 Days	66.7% 4/6 • Number of events 13 • Up to 28 Days	14.3% 1/7 • Number of events 3 • Up to 28 Days	37.5% 3/8 • Number of events 4 • Up to 28 Days	16.7% 1/6 • Number of events 5 • Up to 28 Days
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 2 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	50.0% 3/6 • Number of events 3 • Up to 28 Days	42.9% 3/7 • Number of events 7 • Up to 28 Days	25.0% 2/8 • Number of events 3 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	100.0% 1/1 • Number of events 1 • Up to 28 Days	50.0% 3/6 • Number of events 5 • Up to 28 Days	28.6% 2/7 • Number of events 3 • Up to 28 Days	25.0% 2/8 • Number of events 3 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Abdominal Distension	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	33.3% 2/6 • Number of events 3 • Up to 28 Days	14.3% 1/7 • Number of events 1 • Up to 28 Days	37.5% 3/8 • Number of events 3 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	66.7% 2/3 • Number of events 2 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	33.3% 2/6 • Number of events 6 • Up to 28 Days	14.3% 1/7 • Number of events 2 • Up to 28 Days	25.0% 2/8 • Number of events 2 • Up to 28 Days	16.7% 1/6 • Number of events 1 • Up to 28 Days
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	25.0% 2/8 • Number of events 3 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Flatulence	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	100.0% 1/1 • Number of events 1 • Up to 28 Days	16.7% 1/6 • Number of events 1 • Up to 28 Days	14.3% 1/7 • Number of events 1 • Up to 28 Days	12.5% 1/8 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	16.7% 1/6 • Number of events 1 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Eructation	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	12.5% 1/8 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Retching	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	12.5% 1/8 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	100.0% 1/1 • Number of events 2 • Up to 28 Days	33.3% 2/6 • Number of events 4 • Up to 28 Days	14.3% 1/7 • Number of events 1 • Up to 28 Days	12.5% 1/8 • Number of events 3 • Up to 28 Days	16.7% 1/6 • Number of events 1 • Up to 28 Days
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 2 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	14.3% 1/7 • Number of events 1 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	16.7% 1/6 • Number of events 2 • Up to 28 Days
General disorders Fatigue	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	33.3% 2/6 • Number of events 3 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	25.0% 2/8 • Number of events 2 • Up to 28 Days	16.7% 1/6 • Number of events 1 • Up to 28 Days
General disorders Asthenia	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	12.5% 1/8 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Chills	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	12.5% 1/8 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Feeling Cold	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	12.5% 1/8 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Pain	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	12.5% 1/8 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Pyrexia	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	12.5% 1/8 • Number of events 2 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	14.3% 1/7 • Number of events 1 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Skin and subcutaneous tissue disorders Cold Sweat	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	14.3% 1/7 • Number of events 1 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Vascular disorders Flushing	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	14.3% 1/7 • Number of events 1 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	66.7% 2/3 • Number of events 2 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Abdominal Tenderness	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	100.0% 1/1 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	100.0% 1/1 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Gastrointestinal disorders Steatorrhea	0.00% 0/4 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	100.0% 1/1 • Number of events 1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Feeling Hot	0.00% 0/4 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
General disorders Peripheral Swelling	25.0% 1/4 • Number of events 1 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days
Eye disorders Eye Pain	0.00% 0/4 • Up to 28 Days	33.3% 1/3 • Number of events 1 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/3 • Up to 28 Days	0.00% 0/1 • Up to 28 Days	0.00% 0/6 • Up to 28 Days	0.00% 0/7 • Up to 28 Days	0.00% 0/8 • Up to 28 Days	0.00% 0/6 • Up to 28 Days

Additional Information

Medical Director

Kanyos Bio (A wholly owned subsidiary of Anokion SA)

Phone: +1 857-320-6607

Email: clinicaltrials@anokion.com

Results disclosure agreements

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