Trial Outcomes & Findings for A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses (NCT NCT05218434)

Last Updated: 2024-08-23

Results Overview

The number of participants with recorded treatment emergent adverse events following single and multiple doses of AX-158.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

64 participants

Primary outcome timeframe

Up to 10 days of treatment

Results posted on

2024-08-23

Participant Flow

Study recruitment for this study was undertaken in South Wales in the United Kingdom. A sufficient number of participants were screened in order to successfully recruit 64 eligible participants.

Volunteers were screened to the inclusion/exclusion criteria of the study protocol. The following assessments were performed: Physical exam, Demographics,ECG,Vital signs, Safety Laboratory testing/Urinalysis.

Participant milestones

Participant milestones
Measure	Part A - 5 mg AX-158 Single Oral Dose of 5 mg AX-158 administered on Day 1	Part A - 10 mg AX-158 Single Oral Dose of 10 mg AX-158 administered on Day 1	Part A - 15 mg AX-158 Single Oral Dose of 15 mg AX-158 administered on Day 1	Part A - 25 mg AX-158 Single Oral Dose of 25 mg AX-158 administered on Day 1	Part A - 50 mg AX-158 Single Oral Dose of 50 mg AX-158 administered on Day 1	Part A - Placebo Participants Denotes participants across all Part A cohorts who received matching placebo.	Part B - 15 mg AX-158 Fed/Fasted Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part C - 5 mg AX-158 Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 10 mg AX-158 Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 15 mg AX-158 Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10	Part C - Placebo Denotes participants across all Part C cohorts who received matching placebo.
Overall Study STARTED	6	5	4	4	6	9	8	6	5	6	5
Overall Study COMPLETED	6	5	4	4	6	9	8	6	5	6	5
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - 5mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered on Day 1	Part A - 10mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered on Day 1	Part A - 15mg AX-158 n=4 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1	Part A - 25mg AX-158 n=4 Participants Single Oral Dose of 25 mg AX-158 administered on Day 1	Part A - 50mg AX-158 n=6 Participants Single Oral Dose of 50 mg AX-158 administered on Day 1	Part A - Placebo n=9 Participants Denotes participants across all Part A cohorts who received matching placebo.	Part B - 15mg AX-158 Fed/Fasted n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part C - 5mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 10mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 15mg AX-158 n=6 Participants Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10	Part C - Placebo n=5 Participants Denotes participants across all Part C cohorts who received matching placebo.	Total n=64 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	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	64 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	0 Participants n=42 Participants
Sex: Female, Male Female	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	0 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	64 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	1 Participants n=42 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	63 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 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=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 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	0 Participants n=42 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=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	6 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	62 Participants n=42 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 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	0 Participants n=42 Participants
Height	1.800 Metres STANDARD_DEVIATION 0.0620 • n=5 Participants	1.788 Metres STANDARD_DEVIATION 0.0370 • n=7 Participants	1.780 Metres STANDARD_DEVIATION 0.0594 • n=5 Participants	1.783 Metres STANDARD_DEVIATION 0.0699 • n=4 Participants	1.762 Metres STANDARD_DEVIATION 0.0436 • n=21 Participants	1.783 Metres STANDARD_DEVIATION 0.0532 • n=10 Participants	1.771 Metres STANDARD_DEVIATION 0.0617 • n=115 Participants	1.747 Metres STANDARD_DEVIATION 0.0592 • n=24 Participants	1.772 Metres STANDARD_DEVIATION 0.0694 • n=42 Participants	1.805 Metres STANDARD_DEVIATION 0.0485 • n=42 Participants	1.734 Metres STANDARD_DEVIATION 0.0488 • n=42 Participants	1.783 Metres STANDARD_DEVIATION 0.0513 • n=42 Participants
Weight	83.2 Kg STANDARD_DEVIATION 12.019 • n=5 Participants	82.62 Kg STANDARD_DEVIATION 5.034 • n=7 Participants	74.60 Kg STANDARD_DEVIATION 8.636 • n=5 Participants	81.53 Kg STANDARD_DEVIATION 12.829 • n=4 Participants	75.55 Kg STANDARD_DEVIATION 6.486 • n=21 Participants	81.24 Kg STANDARD_DEVIATION 10.989 • n=10 Participants	84.34 Kg STANDARD_DEVIATION 11.244 • n=115 Participants	73.25 Kg STANDARD_DEVIATION 9.194 • n=24 Participants	76.74 Kg STANDARD_DEVIATION 11.959 • n=42 Participants	79.88 Kg STANDARD_DEVIATION 12.015 • n=42 Participants	67.78 Kg STANDARD_DEVIATION 2.842 • n=42 Participants	80.01 Kg STANDARD_DEVIATION 9.638 • n=42 Participants
BMI	25.508 kg/m2 STANDARD_DEVIATION 2.1783 • n=5 Participants	25.880 kg/m2 STANDARD_DEVIATION 2.0092 • n=7 Participants	23.580 kg/m2 STANDARD_DEVIATION 2.8956 • n=5 Participants	25.548 kg/m2 STANDARD_DEVIATION 2.5745 • n=4 Participants	24.313 kg/m2 STANDARD_DEVIATION 1.3690 • n=21 Participants	25.557 kg/m2 STANDARD_DEVIATION 3.3519 • n=10 Participants	26.850 kg/m2 STANDARD_DEVIATION 3.0544 • n=115 Participants	24.053 kg/m2 STANDARD_DEVIATION 3.2247 • n=24 Participants	24.392 kg/m2 STANDARD_DEVIATION 3.0302 • n=42 Participants	24.672 kg/m2 STANDARD_DEVIATION 4.5817 • n=42 Participants	22.584 kg/m2 STANDARD_DEVIATION 1.5257 • n=42 Participants	25.143 kg/m2 STANDARD_DEVIATION 2.4850 • n=42 Participants

PRIMARY outcome

Timeframe: Up to 10 days of treatment

The number of participants with recorded treatment emergent adverse events following single and multiple doses of AX-158.

Outcome measures

Outcome measures
Measure	Part A - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered on Day 1	Part A - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered on Day 1	Part A - 15 mg AX-158 n=4 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1	Part A - 25 mg AX-158 n=4 Participants Single Oral Dose of 25 mg AX-158 administered on Day 1	Part A - 50 mg AX-158 n=6 Participants Single Oral Dose of 50 mg AX-158 administered on Day 1	Part B - 15 mg AX-158 Fed State n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part B - 15 mg AX-158 Fasted n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part C - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 15 mg AX-158 n=6 Participants Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10	Part A - Placebo n=9 Participants Denotes participants across all Part A cohorts who received matching placebo.	Part C - Placebo n=5 Participants Denotes participants across all Part C cohorts who received matching placebo.
Number of Participants With Treatment-Emergent Adverse Events	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	3 participants	1 participants	0 participants	1 participants	4 participants

SECONDARY outcome

Timeframe: Up to 13 days following dose administration

Values calculated for derived PK parameters following samples obtained at the following timepoints: Part A \& B: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, Day 2: 24 hr, 36 hr, Day 3: 48 hr \& Day 4: 72 hr post-Day 1 dose Part C: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 1 dose Day 2: 24 hr, 36 hr post-Day 1 dose Day 3: 48 hr post-Day 1 dose Day 4: 72 hr post-Day 1 dose Day 5: prior to dose Day 10: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 10 dose Day 11: 24 hr, 36 hr post-Day 10 dose Day 12: 48 hr post-Day 10 dose Day 13: 72 hr post-Day 10 dose

Outcome measures

Outcome measures
Measure	Part A - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered on Day 1	Part A - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered on Day 1	Part A - 15 mg AX-158 n=4 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1	Part A - 25 mg AX-158 n=4 Participants Single Oral Dose of 25 mg AX-158 administered on Day 1	Part A - 50 mg AX-158 n=6 Participants Single Oral Dose of 50 mg AX-158 administered on Day 1	Part B - 15 mg AX-158 Fed State n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part B - 15 mg AX-158 Fasted n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part C - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 15 mg AX-158 n=6 Participants Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10	Part A - Placebo Denotes participants across all Part A cohorts who received matching placebo.	Part C - Placebo Denotes participants across all Part C cohorts who received matching placebo.
Maximal Plasma Concentration (Cmax)	0.0831 µg/mL Geometric Coefficient of Variation 16.3	0.174 µg/mL Geometric Coefficient of Variation 9.7	0.29 µg/mL Geometric Coefficient of Variation 10	0.487 µg/mL Geometric Coefficient of Variation 15.8	0.86 µg/mL Geometric Coefficient of Variation 18.9	0.237 µg/mL Geometric Coefficient of Variation 20.7	0.273 µg/mL Geometric Coefficient of Variation 26.3	0.108 µg/mL Geometric Coefficient of Variation 7.1	0.194 µg/mL Geometric Coefficient of Variation 15.4	0.298 µg/mL Geometric Coefficient of Variation 17.5	—	—

SECONDARY outcome

Timeframe: Up to 13 days following dose administration

Outcome measures

Outcome measures
Measure	Part A - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered on Day 1	Part A - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered on Day 1	Part A - 15 mg AX-158 n=4 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1	Part A - 25 mg AX-158 n=4 Participants Single Oral Dose of 25 mg AX-158 administered on Day 1	Part A - 50 mg AX-158 n=6 Participants Single Oral Dose of 50 mg AX-158 administered on Day 1	Part B - 15 mg AX-158 Fed State n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part B - 15 mg AX-158 Fasted n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part C - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 15 mg AX-158 n=6 Participants Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10	Part A - Placebo Denotes participants across all Part A cohorts who received matching placebo.	Part C - Placebo Denotes participants across all Part C cohorts who received matching placebo.
Total Plasma Drug Exposure (AUC0-t)	1.07 h*µg/mL Geometric Coefficient of Variation 35.6	2.06 h*µg/mL Geometric Coefficient of Variation 20.8	3.87 h*µg/mL Geometric Coefficient of Variation 25.2	6.88 h*µg/mL Geometric Coefficient of Variation 34	11.9 h*µg/mL Geometric Coefficient of Variation 24.6	3.3 h*µg/mL Geometric Coefficient of Variation 36.3	3.43 h*µg/mL Geometric Coefficient of Variation 34	1.67 h*µg/mL Geometric Coefficient of Variation 22.5	2.65 h*µg/mL Geometric Coefficient of Variation 38.6	4.97 h*µg/mL Geometric Coefficient of Variation 28.5	—	—

SECONDARY outcome

Timeframe: Up to 13 days following dose administration

Outcome measures

Outcome measures
Measure	Part A - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered on Day 1	Part A - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered on Day 1	Part A - 15 mg AX-158 n=4 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1	Part A - 25 mg AX-158 n=4 Participants Single Oral Dose of 25 mg AX-158 administered on Day 1	Part A - 50 mg AX-158 n=6 Participants Single Oral Dose of 50 mg AX-158 administered on Day 1	Part B - 15 mg AX-158 Fed State n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part B - 15 mg AX-158 Fasted n=8 Participants Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast and administered on Day 1 in a fasted state in treatment period 2.	Part C - 5 mg AX-158 n=6 Participants Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 10 mg AX-158 n=5 Participants Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 15 mg AX-158 n=6 Participants Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10	Part A - Placebo Denotes participants across all Part A cohorts who received matching placebo.	Part C - Placebo Denotes participants across all Part C cohorts who received matching placebo.
Terminal Half Life (t1/2)	8.94 h Geometric Coefficient of Variation 18.4	8.48 h Geometric Coefficient of Variation 13.1	8.56 h Geometric Coefficient of Variation 22.1	10.6 h Geometric Coefficient of Variation 25.4	9.58 h Geometric Coefficient of Variation 10.5	8.19 h Geometric Coefficient of Variation 25.6	8.44 h Geometric Coefficient of Variation 18.8	9.7 h Geometric Coefficient of Variation 4.7	8.41 h Geometric Coefficient of Variation 21.4	9.84 h Geometric Coefficient of Variation 20.9	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A - 5 mg AX-158 n=6 participants at risk Single Oral Dose of 5 mg AX-158 administered on Day 1	Part A - 10 mg AX-158 n=5 participants at risk Single Oral Dose of 10 mg AX-158 administered on Day 1	Part A - 15 mg AX-158 n=4 participants at risk Single Oral Dose of 15 mg AX-158 administered on Day 1	Part A - 25 mg AX-158 n=4 participants at risk Single Oral Dose of 25 mg AX-158 administered on Day 1	Part A - 50 mg AX-158 n=6 participants at risk Single Oral Dose of 50 mg AX-158 administered on Day 1	Part A - Placebo n=9 participants at risk Denotes participants across all Part A cohorts who received matching placebo.	Part B - 15 mg AX-158 Fed n=8 participants at risk Single Oral Dose of 15 mg AX-158 administered on Day 1 of treatment period 1 in the fed state following a high-fat breakfast.	Part B - 15 mg AX-158 Fasted n=8 participants at risk Single Oral Dose of 15 mg AX-158 administered on Day 1 in a fasted state in treatment period 2.	Part C - 5 mg AX-158 n=6 participants at risk Single Oral Dose of 5 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 10 mg AX-158 n=5 participants at risk Single Oral Dose of 10 mg AX-158 administered once daily from Day 1 to Day 10	Part C - 15 mg AX-158 n=6 participants at risk Single Oral Dose of 15 mg AX-158 administered once daily from Day 1 to Day 10	Part C - Placebo n=5 participants at risk Denotes participants across all Part C cohorts who received matching placebo.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	11.1% 1/9 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	20.0% 1/5 • Number of events 3 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov
Nervous system disorders Headache	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	16.7% 1/6 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/9 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	12.5% 1/8 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	16.7% 1/6 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	20.0% 1/5 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov
Immune system disorders Seasonal Allergy	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/9 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	12.5% 1/8 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov
Psychiatric disorders Anxiety	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/9 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	16.7% 1/6 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov
Gastrointestinal disorders Abdominal Distension	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/9 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	16.7% 1/6 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/9 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	20.0% 1/5 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/4 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/9 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/8 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/5 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	0.00% 0/6 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov	20.0% 1/5 • Number of events 1 • Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks Adverse Event and Reporting Descriptions are reported in line with definitions defined by clinicaltrials.gov

Additional Information

Dr Annelize Koch

Simbec Orion

Phone: 01443694313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place