Trial Outcomes & Findings for Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes (NCT NCT04556760)

Results Overview

The change from baseline in glucose AUC(0-4) was analysed to determine the Pharmacodynamic (PD) effect of AZD9567 compared to Prednisolone following a standardised Mixed meal tolerance test (MMTT). In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

On Days -1 (baseline), and Days 4 (Treatment period 1 and 2)

Results posted on

2024-07-18

Participant Flow

This study was conducted in Germany between 26 November 2020 and 09 June 2021.

Patients with type 2 diabetes mellitus who met all the eligibility criteria were randomised in a ratio of 1:1 to a cohort and sequence group. Each cohort was treated for two 72 hour periods in a cross-over design, with a 3-week washout period between treatment periods.

Participant milestones

Participant milestones
Measure	Cohort 1: 72 mg AZD9567 First, Then 40 mg Prednisolone Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone	Cohort 1:40 mg Prednisolone First, Then 72 mg AZD9567 Patients were randomised in a ratio of 1:1 to receive 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2: 40 mg AZD9567 First, Then 20 mg Prednisolone Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone	Cohort 2: 20mg Prednisolone First, Then 40 mg AZD9567 Patients were randomised in a ratio of 1:1 to receive 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo First, Then 5 mg Prednisolone Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone	Cohort 3: 5 mg Prednisolone First, Then Placebo Patients were randomised in a ratio of 1:1 to receive 5 mg prednisolone followed by placebo
Treatment Period 1 (72 Hours) STARTED	14	14	5	4	4	5
Treatment Period 1 (72 Hours) COMPLETED	14	13	5	3	4	5
Treatment Period 1 (72 Hours) NOT COMPLETED	0	1	0	1	0	0
Washout Period (3 Weeks) STARTED	14	13	5	3	4	5
Washout Period (3 Weeks) COMPLETED	14	13	5	3	4	5
Washout Period (3 Weeks) NOT COMPLETED	0	0	0	0	0	0
Treatment Period 2 (72 Hours) STARTED	14	13	5	3	4	5
Treatment Period 2 (72 Hours) COMPLETED	14	13	5	3	4	5
Treatment Period 2 (72 Hours) NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: 72 mg AZD9567 First, Then 40 mg Prednisolone Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone	Cohort 1:40 mg Prednisolone First, Then 72 mg AZD9567 Patients were randomised in a ratio of 1:1 to receive 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2: 40 mg AZD9567 First, Then 20 mg Prednisolone Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone	Cohort 2: 20mg Prednisolone First, Then 40 mg AZD9567 Patients were randomised in a ratio of 1:1 to receive 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo First, Then 5 mg Prednisolone Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone	Cohort 3: 5 mg Prednisolone First, Then Placebo Patients were randomised in a ratio of 1:1 to receive 5 mg prednisolone followed by placebo
Treatment Period 1 (72 Hours) Withdrawal by Subject	0	1	0	0	0	0
Treatment Period 1 (72 Hours) Positive SARS-CoV-2 rapid test for patient's daughter	0	0	0	1	0	0

Baseline Characteristics

Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Total n=44 Participants Total of all reporting groups
Age, Continuous	67.3 Years STANDARD_DEVIATION 6.41 • n=5 Participants	64.4 Years STANDARD_DEVIATION 9.32 • n=7 Participants	66.6 Years STANDARD_DEVIATION 5.36 • n=5 Participants	66.6 Years STANDARD_DEVIATION 6.75 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	37 Participants n=4 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
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	44 Participants n=4 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
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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	42 Participants n=4 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
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

PRIMARY outcome

Timeframe: On Days -1 (baseline), and Days 4 (Treatment period 1 and 2)

Population: Full Analysis Set (FAS) consisted of all randomised patients who received at least 1 dose of study treatment.

The change from baseline in glucose AUC(0-4) was analysed to determine the Pharmacodynamic (PD) effect of AZD9567 compared to Prednisolone following a standardised Mixed meal tolerance test (MMTT). In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in Glucose Area Under the Plasma Concentration Versus Time Curve From Zero to 4 Hours Post-dose AUC(0-4) Prednisolone	-57.0768 minutemillimole/liter (minmmol/L) Standard Error 63.8762	-40.6842 minutemillimole/liter (minmmol/L) Standard Error 141.7154	-184.9677 minutemillimole/liter (minmmol/L) Standard Error 88.9807	—	—	—
Change From Baseline in Glucose Area Under the Plasma Concentration Versus Time Curve From Zero to 4 Hours Post-dose AUC(0-4) AZD9567	-190.0296 minutemillimole/liter (minmmol/L) Standard Error 63.8805	-182.7172 minutemillimole/liter (minmmol/L) Standard Error 149.8600	—	—	—	—
Change From Baseline in Glucose Area Under the Plasma Concentration Versus Time Curve From Zero to 4 Hours Post-dose AUC(0-4) Placebo	—	—	-311.8506 minutemillimole/liter (minmmol/L) Standard Error 88.5443	—	—	—

SECONDARY outcome

Timeframe: 48 to 72 hours

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

The mean glucose levels in mmol/L at 48-72 h was analysed to determine the effect of AZD9567 on CGM compared to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Mean Glucose Level as Determined Via the Continuous Glucose Monitoring (CGM) System AZD9567	8.5730 millimole/liter (mmol/L) per day Standard Error 0.3114	7.7870 millimole/liter (mmol/L) per day Standard Error 0.2517	—	—	—	—
Mean Glucose Level as Determined Via the Continuous Glucose Monitoring (CGM) System Prednisolone	10.0797 millimole/liter (mmol/L) per day Standard Error 0.3150	8.8969 millimole/liter (mmol/L) per day Standard Error 0.2494	7.4238 millimole/liter (mmol/L) per day Standard Error 0.2889	—	—	—
Mean Glucose Level as Determined Via the Continuous Glucose Monitoring (CGM) System Placebo	—	—	7.2638 millimole/liter (mmol/L) per day Standard Error 0.2888	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to 72 hours (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

The mean glucose level in mmol/L was analysed to determine the effect of AZD9567 on CGM compared to prednisolone. For the calculation of the rise in mean glucose levels, the baseline was the average of the values from -24 hours to first dosing on Day 1 of each period. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing AZD9567 (24 to 48 h)	0.8011 mmol/L per day Standard Error 0.2978	0.5428 mmol/L per day Standard Error 0.2483	—	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing AZD9567 (00 to 24 hours [h])	1.2071 mmol/L per day Standard Error 0.2869	0.4070 mmol/L per day Standard Error 0.2509	—	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing Prednisolone (00 to 24 h)	2.7086 mmol/L per day Standard Error 0.2938	1.2545 mmol/L per day Standard Error 0.2460	0.3123 mmol/L per day Standard Error 0.1549	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing Placebo (00 to 24 h)	—	—	-0.0477 mmol/L per day Standard Error 0.1547	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing Prednisolone (24 to 48 h)	2.6653 mmol/L per day Standard Error 0.3044	1.3206 mmol/L per day Standard Error 0.2448	-0.2415 mmol/L per day Standard Error 0.2898	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing Placebo (24 to 48 h)	—	—	-0.3260 mmol/L per day Standard Error 0.2894	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing AZD9567 (48 to 72 h)	0.8529 mmol/L per day Standard Error 0.3210	0.0744 mmol/L per day Standard Error 0.2714	—	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing Prednisolone (48 to 72 h)	2.4527 mmol/L per day Standard Error 0.3274	1.2174 mmol/L per day Standard Error 0.2664	-0.2202 mmol/L per day Standard Error 0.2229	—	—	—
Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing Placebo (48 to 72 h)	—	—	-0.3500 mmol/L per day Standard Error 0.2224	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Pharmacodynamic effects (fasting glucose) of AZD9567 following a MMTT were evaluated as compared to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in Fasting Glucose AZD9567	-1.14 mmol/L Standard Error 0.17	-0.95 mmol/L Standard Error 0.36	—	—	—	—
Change From Baseline in Fasting Glucose Prednisolone	-1.06 mmol/L Standard Error 0.17	-0.91 mmol/L Standard Error 0.35	-1.15 mmol/L Standard Error 0.20	—	—	—
Change From Baseline in Fasting Glucose Placebo	—	—	-1.15 mmol/L Standard Error 0.20	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on insulin AUC(0-4) were assessed following MMTT compared to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Insulin) AZD9567	15319.3857 minutepicomole/liter (minpmole/L) Standard Error 4165.9135	13413.1929 minutepicomole/liter (minpmole/L) Standard Error 4791.9873	—	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Insulin) Prednisolone	-5179.3659 minutepicomole/liter (minpmole/L) Standard Error 3989.2683	10091.7869 minutepicomole/liter (minpmole/L) Standard Error 5461.2631	4915.4115 minutepicomole/liter (minpmole/L) Standard Error 7049.5460	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Insulin) Placebo	—	—	2216.5532 minutepicomole/liter (minpmole/L) Standard Error 7049.0432	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on glucagon AUC(0-4) were assessed following MMTT in comparison to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon) AZD9567	-36.9846 min*pmol/L Standard Error 216.5777	552.0634 min*pmol/L Standard Error 213.9300	—	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon) Prednisolone	965.6018 min*pmol/L Standard Error 216.6054	511.0798 min*pmol/L Standard Error 213.5970	259.9835 min*pmol/L Standard Error 298.9801	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon) Placebo	—	—	361.3971 min*pmol/L Standard Error 348.5104	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on GLP-1 AUC(0-4) were assessed following MMTT in comparison to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon-like Peptide-1 [GLP-1]) AZD9567	615.9803 min*pmol/L Standard Error 328.8418	322.5690 min*pmol/L Standard Error 454.2028	—	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon-like Peptide-1 [GLP-1]) Prednisolone	1841.8853 min*pmol/L Standard Error 328.8877	789.5492 min*pmol/L Standard Error 450.2548	575.6726 min*pmol/L Standard Error 318.1088	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon-like Peptide-1 [GLP-1]) Placebo	—	—	200.3565 min*pmol/L Standard Error 317.6326	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on GIP AUC(0-4) were assessed following MMTT in comparison to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucose-dependent Insulin Releasing Polypeptide [GIP]) AZD9567	3658.9885 min*pmol/L Standard Error 584.5079	3842.9307 min*pmol/L Standard Error 1303.1553	—	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucose-dependent Insulin Releasing Polypeptide [GIP]) Prednisolone	3293.3563 min*pmol/L Standard Error 596.7472	3654.6947 min*pmol/L Standard Error 1289.5516	3271.5164 min*pmol/L Standard Error 823.9967	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucose-dependent Insulin Releasing Polypeptide [GIP]) Placebo	—	—	2210.0670 min*pmol/L Standard Error 827.7335	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on C-peptide AUC(0-4) were assessed through a MMTT in comparison to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in AUC(0-4) on C-peptide AZD9567	85.3305 minutenanomole/L (minnmol/L) Standard Error 13.4279	82.1134 minutenanomole/L (minnmol/L) Standard Error 22.9858	—	—	—	—
Change From Baseline in AUC(0-4) on C-peptide Prednisolone	24.9094 minutenanomole/L (minnmol/L) Standard Error 13.4282	55.6606 minutenanomole/L (minnmol/L) Standard Error 22.6155	24.7245 minutenanomole/L (minnmol/L) Standard Error 22.2183	—	—	—
Change From Baseline in AUC(0-4) on C-peptide Placebo	—	—	0.7002 minutenanomole/L (minnmol/L) Standard Error 22.0424	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on ΔI10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in Ratio of Insulin to Glucose Level Between 10 and 0 Minutes (ΔI10/ΔG10) Placebo	—	—	-0.3532 Ratio Standard Error 0.6893	—	—	—
Change From Baseline in Ratio of Insulin to Glucose Level Between 10 and 0 Minutes (ΔI10/ΔG10) AZD9567	-0.5249 Ratio Standard Error 0.6632	NA Ratio Standard Error NA Convergence was not met thus no data are available.	—	—	—	—
Change From Baseline in Ratio of Insulin to Glucose Level Between 10 and 0 Minutes (ΔI10/ΔG10) Prednisolone	0.0774 Ratio Standard Error 0.6674	NA Ratio Standard Error NA Convergence was not met thus no data are available.	-0.8153 Ratio Standard Error 0.8305	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on ΔI30/ΔG30 of beta cell function from the MMTT compared to Prednisolone was evaluated. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in Ratio of Insulin to Glucose Level Between 30 and 0 Minutes [ΔI30/ΔG30]) AZD9567	0.1203 Ratio Standard Error 0.0726	0.1824 Ratio Standard Error 0.0773	—	—	—	—
Change From Baseline in Ratio of Insulin to Glucose Level Between 30 and 0 Minutes [ΔI30/ΔG30]) Prednisolone	0.0530 Ratio Standard Error 0.0755	0.0943 Ratio Standard Error 0.1264	-0.1047 Ratio Standard Error 0.0665	—	—	—
Change From Baseline in Ratio of Insulin to Glucose Level Between 30 and 0 Minutes [ΔI30/ΔG30]) Placebo	—	—	0.0209 Ratio Standard Error 0.0599	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on ΔC10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in Ratio of C-peptide to Glucose Level Between 10 and 0 Minutes (ΔC10/ΔG10) AZD9567	-0.0004 Ratio Standard Error 0.0095	0.0059 Ratio Standard Error 0.0041	—	—	—	—
Change From Baseline in Ratio of C-peptide to Glucose Level Between 10 and 0 Minutes (ΔC10/ΔG10) Prednisolone	-0.0103 Ratio Standard Error 0.0092	0.0026 Ratio Standard Error 0.0047	-0.0033 Ratio Standard Error 0.0064	—	—	—
Change From Baseline in Ratio of C-peptide to Glucose Level Between 10 and 0 Minutes (ΔC10/ΔG10) Placebo	—	—	-0.0024 Ratio Standard Error 0.0057	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on ΔC30/ΔG30 of beta cell function from the MMTT compared to Prednisolone was evaluated. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in Ratio of C-peptide to Glucose Level Between 30 and 0 Minutes (ΔC30/ΔG30) AZD9567	0.0012 Ratio Standard Error 0.0005	0.0007 Ratio Standard Error 0.0005	—	—	—	—
Change From Baseline in Ratio of C-peptide to Glucose Level Between 30 and 0 Minutes (ΔC30/ΔG30) Prednisolone	0.0005 Ratio Standard Error 0.0005	0.0004 Ratio Standard Error 0.0005	-0.0010 Ratio Standard Error 0.0005	—	—	—
Change From Baseline in Ratio of C-peptide to Glucose Level Between 30 and 0 Minutes (ΔC30/ΔG30) Placebo	—	—	0.0002 Ratio Standard Error 0.0005	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

The concentration of potassium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary potassium (U-K) excretion compared to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in 24-hour Urinary Potassium Excretion AZD9567	-2.92 mmol/day Standard Error 3.27	-6.05 mmol/day Standard Error 4.30	—	—	—	—
Change From Baseline in 24-hour Urinary Potassium Excretion Prednisolone	-1.19 mmol/day Standard Error 3.27	4.92 mmol/day Standard Error 4.29	-2.49 mmol/day Standard Error 9.08	—	—	—
Change From Baseline in 24-hour Urinary Potassium Excretion Placebo	—	—	-2.85 mmol/day Standard Error 9.07	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

The concentration of sodium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary-sodium (U-Na) excretion compared to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in 24-hour Urinary Sodium Excretion AZD9567	17.4 mmol/day Standard Error 11.0	39.9 mmol/day Standard Error 20.4	—	—	—	—
Change From Baseline in 24-hour Urinary Sodium Excretion Prednisolone	9.7 mmol/day Standard Error 11.0	17.6 mmol/day Standard Error 20.3	-18.1 mmol/day Standard Error 21.4	—	—	—
Change From Baseline in 24-hour Urinary Sodium Excretion Placebo	—	—	12.9 mmol/day Standard Error 21.3	—	—	—

SECONDARY outcome

Timeframe: Upto 30 hours post dose (Treatment period 1 and 2)

Population: Pharmacokinetic analysis set (PKAS) consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or adverse events (AEs) considered to have an effect upon PK.

AUClast of AZD9567 following once daily dosing was evaluated.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUClast)	34400 hournanomole/liter (hnmol/L) Geometric Coefficient of Variation 42.97	18410 hournanomole/liter (hnmol/L) Geometric Coefficient of Variation 46.06	—	—	—	—

SECONDARY outcome

Timeframe: 24 hours post dose

Population: PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.

AUC(0-24) of AZD9567 following once daily dosing was evaluated.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours Post-dose [AUC(0-24)]	32920 h*nmol/L Geometric Coefficient of Variation 41.32	17790 h*nmol/L Geometric Coefficient of Variation 44.86	—	—	—	—

SECONDARY outcome

Timeframe: 6 hours post dose

Population: PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.

AUC(0-6) of AZD9567 following once daily dosing was evaluated.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Area Under the Plasma Concentration Versus Time Curve From Zero to 6 Hours Post-dose [AUC(0-6)]	17050 h*nmol/L Geometric Coefficient of Variation 30.45	9914 h*nmol/L Geometric Coefficient of Variation 35.06	—	—	—	—

SECONDARY outcome

Timeframe: Upto 30 hours post dose (Treatment period 1 and 2)

Population: PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.

Cmax of AZD9567 following once daily dosing was evaluated.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Maximum Observed Drug Concentration (Cmax)	4501 nmol/L Geometric Coefficient of Variation 26.90	2939 nmol/L Geometric Coefficient of Variation 31.50	—	—	—	—

SECONDARY outcome

Timeframe: Upto 30 hours post dose (Treatment period 1 and 2)

Population: PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.

Tmax of AZD9567 following once daily dosing was evaluated.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Time to Reach Maximum Observed Drug Concentration (Tmax)	0.50 hours Interval 0.25 to 1.5	0.50 hours Interval 0.5 to 1.0	—	—	—	—

SECONDARY outcome

Timeframe: Upto 30 hours post dose (Treatment period 1 and 2)

Population: PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.

t½λz of AZD9567 following once daily dosing was evaluated.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Terminal Elimination Half-life (t½λz)	6.99 hours Standard Deviation 1.44	6.16 hours Standard Deviation 1.08	—	—	—	—

SECONDARY outcome

Timeframe: Upto 30 hours post dose (Treatment period 1 and 2)

Population: PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.

CL/F of AZD9567 following once daily dosing was evaluated.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Apparent Total Body Clearance of Drug From Plasma After Extravascular (CL/F)	4.766 Liter/hour (L/h) Standard Deviation 1.896	4.924 Liter/hour (L/h) Standard Deviation 2.098	—	—	—	—

SECONDARY outcome

Timeframe: Upto 30 hours post dose (Treatment period 1 and 2)

Population: PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.

Vz/F of AZD9567 was derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Apparent Volume of Distribution Following Extravascular Administration (Vz/F)	45.11 Liter Standard Deviation 11.39	41.75 Liter Standard Deviation 14.19	—	—	—	—

SECONDARY outcome

Timeframe: On Days 3 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Relationship between AZD9567 exposure and inhibition of LPS-stimulated TNFα release for high and low dose comparison (Cohort 1 and Cohort 2) was assessed. LPS-stimulated TNFα concentration was measured.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Tumour Necrosis Factor Alpha (TNFα) Concentrations AZD9567 (0h)	21000.1 nanogram/liter (ng/L) Standard Deviation 15413.92	23525.0 nanogram/liter (ng/L) Standard Deviation 15260.57	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations Prednisolone (0h)	21361.5 nanogram/liter (ng/L) Standard Deviation 18124.60	12385.0 nanogram/liter (ng/L) Standard Deviation 11835.31	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations AZD9567 (1h)	9100.2 nanogram/liter (ng/L) Standard Deviation 6248.93	8122.5 nanogram/liter (ng/L) Standard Deviation 5303.16	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations Prednisolone (1h)	3581.1 nanogram/liter (ng/L) Standard Deviation 3642.93	3617.5 nanogram/liter (ng/L) Standard Deviation 1552.62	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations AZD9567 (2h)	8170.7 nanogram/liter (ng/L) Standard Deviation 5053.69	8098.0 nanogram/liter (ng/L) Standard Deviation 7709.06	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations Prednisolone (2h)	1648.2 nanogram/liter (ng/L) Standard Deviation 1109.64	1421.1 nanogram/liter (ng/L) Standard Deviation 591.80	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations AZD9567 (4h)	7534.6 nanogram/liter (ng/L) Standard Deviation 4519.50	8898.8 nanogram/liter (ng/L) Standard Deviation 5249.73	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations Prednisolone (4h)	2293.1 nanogram/liter (ng/L) Standard Deviation 1329.60	4292.0 nanogram/liter (ng/L) Standard Deviation 3207.76	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations AZD9567 (8h)	10674.4 nanogram/liter (ng/L) Standard Deviation 7731.94	13023.8 nanogram/liter (ng/L) Standard Deviation 8946.33	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations Prednisolone (8h)	4585.7 nanogram/liter (ng/L) Standard Deviation 4453.61	7247.5 nanogram/liter (ng/L) Standard Deviation 2889.87	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations AZD9567 (12h)	13332.5 nanogram/liter (ng/L) Standard Deviation 10831.44	14695.0 nanogram/liter (ng/L) Standard Deviation 11422.87	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations Prednisolone (12h)	12415.5 nanogram/liter (ng/L) Standard Deviation 9474.44	16790.0 nanogram/liter (ng/L) Standard Deviation 8010.23	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations AZD9567 (24h)	22136.7 nanogram/liter (ng/L) Standard Deviation 13414.45	19741.3 nanogram/liter (ng/L) Standard Deviation 11048.74	—	—	—	—
Tumour Necrosis Factor Alpha (TNFα) Concentrations Prednisolone (24h)	23292.9 nanogram/liter (ng/L) Standard Deviation 15548.12	20920.0 nanogram/liter (ng/L) Standard Deviation 14802.66	—	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Effects of AZD9567 on free fatty acids were evaluated following a MMTT compared to prednisolone. In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Free Fatty Acids) Placebo	—	—	4.8995 min*mmol/L Standard Error 3.7153	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Free Fatty Acids) AZD9567	-18.1304 min*mmol/L Standard Error 1.7543	-14.0582 min*mmol/L Standard Error 3.7038	—	—	—	—
Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Free Fatty Acids) Prednisolone	-14.1238 min*mmol/L Standard Error 1.7542	-19.8117 min*mmol/L Standard Error 3.7060	-4.1625 min*mmol/L Standard Error 3.7212	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

The HOMA-IR was calculated based on glucose and insulin measured prior to MMTT. HOMA-IR= Glucose(mmol/L) x Insulin (mU/L) / 22.5 HOMA-IR score estimates the degree of insulin resistance. Higher range indicates greater insulin resistance (i.e. high diabetes risk), while lower range indicates insulin sensitivity (i.e. low diabetes risk) In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in Homeostatic Model Assessment- Insulin Resistance (HOMA-IR) AZD9567	-0.4406 Score Standard Deviation 1.9875	-0.1738 Score Standard Deviation 0.7576	—	—	—	—
Change From Baseline in Homeostatic Model Assessment- Insulin Resistance (HOMA-IR) Prednisolone	-0.7023 Score Standard Deviation 1.5896	0.0721 Score Standard Deviation 0.9606	-0.5662 Score Standard Deviation 0.7364	—	—	—
Change From Baseline in Homeostatic Model Assessment- Insulin Resistance (HOMA-IR) Placebo	—	—	-0.9280 Score Standard Deviation 0.8173	—	—	—

SECONDARY outcome

Timeframe: On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)

Population: FAS consisted of all randomised patients who received at least 1 dose of study treatment.

Insulin sensitivity is a term used to indicate the responsiveness of the peripheral tissue cells to insulin, and their resultant capacity to uptake glucose out of the bloodstream. HOMA-S score estimates the degree of insulin sensitivity. HOMA-S was calculated as the reciprocal of HOMA-IR. Higher values indicates greater insulin sensitivity (i.e. low diabetes risk), while lower values indicates insulin resistance (i.e. high diabetes risk) In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Change From Baseline in HOMA-insulin Sensitivity (HOMA-S) AZD9567	0.0134 Score Standard Deviation 0.2352	-0.0360 Score Standard Deviation 0.1990	—	—	—	—
Change From Baseline in HOMA-insulin Sensitivity (HOMA-S) Prednisolone	0.0328 Score Standard Deviation 0.1400	-0.0799 Score Standard Deviation 0.2077	0.0750 Score Standard Deviation 0.0949	—	—	—
Change From Baseline in HOMA-insulin Sensitivity (HOMA-S) Placebo	—	—	0.1468 Score Standard Deviation 0.0930	—	—	—

SECONDARY outcome

Timeframe: From screening up to 79 days

Population: Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention.

Safety and tolerability of AZD9567 was assessed.

Outcome measures

Outcome measures
Measure	Cohort 1 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567	Cohort 2 n=27 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3 n=8 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 2: Prednisolone 20mg n=8 Participants Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 3: Placebo n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg n=9 Participants Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Number of Participants With Adverse Events Any AE with outcome = death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Any SAE (including events with outcome = death)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Any Adverse Event (AE)	4 Participants	7 Participants	2 Participants	5 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Any AE leading to discontinuation of Investigational Product	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Any AE leading to drug interruption	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Any AE leading to withdrawal from study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Cohort 1: AZD9567 72mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 1: Prednisolone 40mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 2: AZD9567 40mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: Prednisolone 20mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 3: Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3: Prednisolone 5mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1: AZD9567 72mg n=27 participants at risk Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956	Cohort 1: Prednisolone 40mg n=27 participants at risk Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956	Cohort 2: AZD9567 40mg n=8 participants at risk Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567	Cohort 2: Prednisolone 20mg n=8 participants at risk Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD956	Cohort 3: Placebo n=9 participants at risk Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo	Cohort 3: Prednisolone 5mg n=9 participants at risk Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
Infections and infestations Cellulitis	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Infections and infestations Conjunctivitis	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Infections and infestations Nasopharyngitis	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Nervous system disorders Dizziness	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	12.5% 1/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Nervous system disorders Headache	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	12.5% 1/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	25.0% 2/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Renal and urinary disorders Pollakiuria	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
General disorders Administration site phlebitis	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
General disorders Catheter site erythema	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
General disorders Fatigue	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
General disorders Mucosal inflammation	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	3.7% 1/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Gastrointestinal disorders Haematochezia	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	12.5% 1/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	12.5% 1/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
General disorders Catheter site related reaction	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	12.5% 1/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Investigations Blood pressure increased	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	12.5% 1/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Gastrointestinal disorders Diarrhoea	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/27 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/8 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	11.1% 1/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.	0.00% 0/9 • From Screening up to Final/ end of treatment visit (Day 79). Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.

Additional Information

Global Clinical Head

AstraZeneca Clinical Study Information Center

Phone: 1-877-240-94 79

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca.
Publication restrictions are in place

Restriction type: OTHER