Trial Outcomes & Findings for Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus (NCT NCT03117998)

NCT ID: NCT03117998

Last Updated: 2023-05-25

Results Overview

Change from Baseline in average daily total insulin use at Week 12

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 154 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2023-05-25

Participant Flow

Participant milestones

Measure	Part A - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 Administered as a repeated SC doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Overall Study STARTED	25	25	25	26	26	27
Overall Study COMPLETED	24	24	21	22	19	24
Overall Study NOT COMPLETED	1	1	4	4	7	3

Reasons for withdrawal

Measure	Part A - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 Administered as a repeated SC doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Overall Study Adverse Event	1	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	2	3	3	0
Overall Study Physician Decision	0	1	1	0	0	0
Overall Study Lost to Follow-up	0	0	0	1	4	0
Overall Study Subject noncompliance	0	0	1	0	0	2
Overall Study Protocol Violation	0	0	0	0	0	1

Baseline Characteristics

Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Part A - 35 mg REMD-477 n=25 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=25 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=25 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=26 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=26 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=27 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Total n=154 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 13.1 • n=5 Participants	43 years STANDARD_DEVIATION 13.7 • n=7 Participants	45 years STANDARD_DEVIATION 14.8 • n=5 Participants	42 years STANDARD_DEVIATION 13.8 • n=4 Participants	38 years STANDARD_DEVIATION 14.1 • n=21 Participants	42 years STANDARD_DEVIATION 14.8 • n=8 Participants	42 years STANDARD_DEVIATION 14.08 • n=8 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	17 Participants n=21 Participants	12 Participants n=8 Participants	92 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	9 Participants n=21 Participants	15 Participants n=8 Participants	62 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	18 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	20 Participants n=7 Participants	24 Participants n=5 Participants	25 Participants n=4 Participants	20 Participants n=21 Participants	22 Participants n=8 Participants	136 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	21 Participants n=4 Participants	23 Participants n=21 Participants	27 Participants n=8 Participants	138 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Body Mass Index	25.8 kg/m^2 STANDARD_DEVIATION 2.88 • n=5 Participants	27.2 kg/m^2 STANDARD_DEVIATION 4.01 • n=7 Participants	27.2 kg/m^2 STANDARD_DEVIATION 3.55 • n=5 Participants	25.9 kg/m^2 STANDARD_DEVIATION 3.38 • n=4 Participants	26.8 kg/m^2 STANDARD_DEVIATION 3.39 • n=21 Participants	25.9 kg/m^2 STANDARD_DEVIATION 3.34 • n=8 Participants	26.5 kg/m^2 STANDARD_DEVIATION 3.42 • n=8 Participants
Baseline Average HbA1c Values	7.54 Percentage STANDARD_DEVIATION 0.159 • n=5 Participants	7.42 Percentage STANDARD_DEVIATION 0.159 • n=7 Participants	7.58 Percentage STANDARD_DEVIATION 0.159 • n=5 Participants	8.05 Percentage STANDARD_DEVIATION 0.153 • n=4 Participants	7.94 Percentage STANDARD_DEVIATION 0.358 • n=21 Participants	7.74 Percentage STANDARD_DEVIATION 0.150 • n=8 Participants	7.71 Percentage STANDARD_DEVIATION 0.190 • n=8 Participants
Baseline Average Daily Total Insulin Use Values	45.99 Units/day STANDARD_DEVIATION 3.194 • n=5 Participants	44.21 Units/day STANDARD_DEVIATION 3.194 • n=7 Participants	47.51 Units/day STANDARD_DEVIATION 3.194 • n=5 Participants	42.60 Units/day STANDARD_DEVIATION 3.299 • n=4 Participants	47.06 Units/day STANDARD_DEVIATION 3.365 • n=21 Participants	50.03 Units/day STANDARD_DEVIATION 3.238 • n=8 Participants	46.23 Units/day STANDARD_DEVIATION 3.247 • n=8 Participants
Time Since Type 1 Diabetes Diagnosis	23.7 years STANDARD_DEVIATION 10.0 • n=5 Participants	25.1 years STANDARD_DEVIATION 12.7 • n=7 Participants	30 years STANDARD_DEVIATION 13.1 • n=5 Participants	21.7 years STANDARD_DEVIATION 11.8 • n=4 Participants	19.6 years STANDARD_DEVIATION 11.7 • n=21 Participants	25.4 years STANDARD_DEVIATION 14.4 • n=8 Participants	24.25 years STANDARD_DEVIATION 12.3 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Change from Baseline in average daily total insulin use at Week 12

Outcome measures

Measure	Part A - 35 mg REMD-477 n=21 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=22 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=15 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=21 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=20 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=22 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Change in Average Daily Total Insulin Use	-6.72 Units/day Standard Error 1.649	-5.25 Units/day Standard Error 1.634	-1.37 Units/day Standard Error 1.881	-7.59 Units/day Standard Error 2.142	-6.64 Units/day Standard Error 2.22	-1.27 Units/day Standard Error 2.103

SECONDARY outcome

Timeframe: Baseline and 13 weeks; AUC glucose timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.

Difference from baseline at Week 13 in AUC glucose concentration following the Mixed Meal Tolerance Test (MMTT) after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=23 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=23 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=21 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Change From Baseline Difference in AUC Glucose Concentrations Following Mixed Meal Tolerance Test (MMTT) - Part A Only	-150.68 min*mg/dL Standard Error 40.472	-115.05 min*mg/dL Standard Error 40.441	-66.00 min*mg/dL Standard Error 43.020	—	—	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change from baseline at Week 12 in average daily 24-h blood glucose as assessed by CGM after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=21 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=21 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=18 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=9 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=8 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=12 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Continuous Glucose Monitoring (CGM) - Change in Average Daily 24-hour Glucose Concentration at Week 12	0.46 mg/dL/day Standard Error 2.561	-5.71 mg/dL/day Standard Error 2.575	0.57 mg/dL/day Standard Error 2.736	2.57 mg/dL/day Standard Error 5.159	-6.05 mg/dL/day Standard Error 5.435	6.08 mg/dL/day Standard Error 4.502

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Part A patients' compliance with the recordings of glucose values on paper diary were low, and greater than 50% of the data was missing.

Change from baseline at Week 12 in the average daily 24-h blood glucose concentration as assessed by seven-point glucose profile after repeated doses of REMD-477. The 7-point blood glucose profiles includes measuring glucose via finger stick, at the following times of the day: before each meal, 2 hours after each meal, and at bedtime. The 7-point glucose profiles were obtained for 3 consecutive days before (Day 1) and for 3 consecutive days during week 12.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=8 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=8 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=4 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=20 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=18 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=19 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Seven-Point Glucose Profile - Change in Average 24-h Glucose Concentrations	11.02 mg/dL/day Standard Error 6.697	-9.43 mg/dL/day Standard Error 6.830	-4.09 mg/dL/day Standard Error 9.336	-4.52 mg/dL/day Standard Error 9.027	-3.71 mg/dL/day Standard Error 9.458	5.07 mg/dL/day Standard Error 9.091

SECONDARY outcome

Timeframe: Baseline and week 12

The product of the ratio of average glucose (Week 12/Baseline) and ratio of average insulin use (Week 12/Baseline).

Outcome measures

Measure	Part A - 35 mg REMD-477 n=17 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=17 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=12 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=13 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=12 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=15 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Summary of the Product of Average Daily 24-h Glucose Ratio and Daily Insulin Use Ratio (Day 78 [Week 12]/Baseline)	0.86 Ratio Standard Error 0.41	0.81 Ratio Standard Error 0.041	0.98 Ratio Standard Error 0.049	0.88 Ratio Standard Error 0.082	0.89 Ratio Standard Error 0.086	0.95 Ratio Standard Error 0.077

SECONDARY outcome

Timeframe: Baseline and 13 weeks

Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=23 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=24 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=21 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=24 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=21 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=24 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Change in Hemoglobin A1c From Baseline at Week 13	-0.67 Percentage Standard Error 0.104	-0.66 Percentage Standard Error 0.105	-0.43 Percentage Standard Error 0.109	-0.64 Percentage Standard Error 0.130	-0.60 Percentage Standard Error 0.134	-0.11 Percentage Standard Error 0.125

SECONDARY outcome

Timeframe: Baseline and 13 weeks

Proportion (percentage) of subjects who achieve HbA1c reduction of ≥ 0.4%, after repeated doses of REMD-477

Outcome measures

Measure	Part A - 35 mg REMD-477 n=24 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=24 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=21 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=24 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=22 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=26 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Percentage of Subjects With HbA1c Reduction of ≥ 0.4% at Week 13	16 Participants	17 Participants	9 Participants	13 Participants	12 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and 13 weeks; AUC C-peptide timepoints: 10 minutes prior and just before (time 0) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.

Population: MMTT was completed in Part A subjects only. MMTT was removed from Part B as part of a protocol amendment, and Part B subjects did not complete the MMTT.

Change from baseline at Week 13 in the C-peptide adjusted AUC following MMTT after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=8 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=12 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=10 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Change in C-peptide Adjusted AUC Following Mixed Meal Tolerance Test (MMTT)	27.33 min*pmol/L Standard Error 107.029	289.93 min*pmol/L Standard Error 87.212	166.99 min*pmol/L Standard Error 96.052	—	—	—

SECONDARY outcome

Timeframe: Baseline and 13 weeks; AUC glucagon timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.

Population: MMTT was completed in Part A subjects only. Part B subjects did not complete the MMTT.

Change from baseline at Week 13 in glucagon adjusted AUC after MMTT challenge, after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=3 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=4 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=3 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Change in Baseline Difference in Glucagon Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) - Part A Only	2398.76 min*pmol/L Standard Error 1172.219	345.14 min*pmol/L Standard Error 1001.903	13.40 min*pmol/L Standard Error 1135.048	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose), Day 85 (Week 13) and Day 162 (Week 24)

Proportion of subjects positive for anti-REMD-477 antibody formation.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=51 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=51 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=51 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Proportion of Subjects With Positive Anti-REMD-477 Antibodies Day 1 (Pre-dose)	2 participants	4 participants	5 participants	—	—	—
Proportion of Subjects With Positive Anti-REMD-477 Antibodies Day 85 (Week 13)	1 participants	1 participants	4 participants	—	—	—
Proportion of Subjects With Positive Anti-REMD-477 Antibodies Day 162 (Week 24)	2 participants	5 participants	4 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose) and Weeks 2, 5, 9, 13 and 16.

REMD-477 serum-concentration after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=25 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=25 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=20 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=20 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Summary of REMD-477 Plasma Concentrations Baseline (Day 1 Pre-dose)	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	—	—
Summary of REMD-477 Plasma Concentrations Week 2	1070 ng/mL Geometric Coefficient of Variation 51.0	3600 ng/mL Geometric Coefficient of Variation 47.9	1390 ng/mL Geometric Coefficient of Variation 47.3	2780 ng/mL Geometric Coefficient of Variation 65.0	—	—
Summary of REMD-477 Plasma Concentrations Week 5	4650 ng/mL Geometric Coefficient of Variation 33.9	12600 ng/mL Geometric Coefficient of Variation 68.7	4460 ng/mL Geometric Coefficient of Variation 54.7	11000 ng/mL Geometric Coefficient of Variation 33.3	—	—
Summary of REMD-477 Plasma Concentrations Week 9	6290 ng/mL Geometric Coefficient of Variation 41.8	18200 ng/mL Geometric Coefficient of Variation 34	6550 ng/mL Geometric Coefficient of Variation 37.5	14600 ng/mL Geometric Coefficient of Variation 26.7	—	—
Summary of REMD-477 Plasma Concentrations Week 13	6390 ng/mL Geometric Coefficient of Variation 45.9	19300 ng/mL Geometric Coefficient of Variation 33.0	7040 ng/mL Geometric Coefficient of Variation 40.6	15700 ng/mL Geometric Coefficient of Variation 27.8	—	—
Summary of REMD-477 Plasma Concentrations Week 16	1430 ng/mL Geometric Coefficient of Variation 110.4	7020 ng/mL Geometric Coefficient of Variation 55.4	1370 ng/mL Geometric Coefficient of Variation 84	5070 ng/mL Geometric Coefficient of Variation 51.1	—	—

SECONDARY outcome

Timeframe: Baseline and 13 weeks

Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=13 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=9 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=12 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=17 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=15 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Change in Hemoglobin A1c at Week 13 in Subjects With Baseline HbA1c ≥7.5%	-1.02 Percentage Standard Error 0.139	-0.94 Percentage Standard Error 0.167	-0.70 Percentage Standard Error 0.141	-0.93 Percentage Standard Error 0.173	-0.54 Percentage Standard Error 0.168	-0.12 Percentage Standard Error 0.182

SECONDARY outcome

Timeframe: Baseline and 13 weeks

Proportion (percentage) of subjects who achieve target HbA1c reduction of ≤ 7.0% at Week 13, after repeated doses of REMD-477

Outcome measures

Measure	Part A - 35 mg REMD-477 n=24 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=24 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=21 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=24 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=22 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=26 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Proportion of Subjects With Targeted Hemoglobin A1C (HbA1c) of ≤ 7.0% at Week 13	16 Participants	19 Participants	9 Participants	12 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change from baseline at Week 12 in percent time spent in target blood glucose range (70-180 mg/dL) after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=19 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=18 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=16 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=12 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Target Blood Glucose Range (70-180 mg/dL) at Week 12	0.55 Percentage of time spent in range Standard Error 2.675	7.38 Percentage of time spent in range Standard Error 2.730	1.54 Percentage of time spent in range Standard Error 2.903	1.13 Percentage of time spent in range Standard Error 3.463	4.20 Percentage of time spent in range Standard Error 3.888	1.19 Percentage of time spent in range Standard Error 3.409

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change from baseline at Week 12 in percent time spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=19 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=18 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=16 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=12 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) at Week 12	0.21 Percentage of time spent in range Standard Error 2.766	-7.99 Percentage of time spent in range Standard Error 2.840	-1.11 Percentage of time spent in range Standard Error 3.015	1.74 Percentage of time spent in range Standard Error 3.788	-5.02 Percentage of time spent in range Standard Error 4.242	-0.65 Percentage of time spent in range Standard Error 3.731

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=19 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=18 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=16 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=12 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) at Week 12	-0.82 Percentage of time spent in range Standard Error 0.773	0.05 Percentage of time spent in range Standard Error 0.792	-0.03 Percentage of time spent in range Standard Error 0.483	-2.85 Percentage of time spent in range Standard Error 1.022	0.85 Percentage of time spent in range Standard Error 1.150	-0.59 Percentage of time spent in range Standard Error 1.010

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) after repeated doses of REMD-477.

Outcome measures

Measure	Part A - 35 mg REMD-477 n=19 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=18 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=16 Participants Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=12 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=16 Participants Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) at Week 12	-0.15 Percentage of time spent in range Standard Error 0.452	0.27 Percentage of time spent in range Standard Error 0.457	-0.03 Percentage of time spent in range Standard Error 0.483	-1.31 Percentage of time spent in range Standard Error 0.450	.25 Percentage of time spent in range Standard Error 0.512	-0.67 Percentage of time spent in range Standard Error 0.448

Adverse Events

Part A - 35 mg REMD-477

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Part A - 70 mg REMD-477

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Part A - Matching Placebo

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Part B - 35 mg REMD-477

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Part B - 70 mg REMD-477

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Part B - Matching Placebo

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A - 35 mg REMD-477 n=25 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=25 participants at risk Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=25 participants at risk Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=26 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=26 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=27 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes
Infections and infestations Appendicitis	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Eye disorders Diabetic retinopathy	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Nervous system disorders Hypoglycaemic unconsciousness	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.7% 1/27 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Nervous system disorders Syncope	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.7% 1/27 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).

Other adverse events

Measure	Part A - 35 mg REMD-477 n=25 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - 70 mg REMD-477 n=25 participants at risk Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part A - Matching Placebo n=25 participants at risk Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes	Part B - 35 mg REMD-477 n=26 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - 70 mg REMD-477 n=26 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes	Part B - Matching Placebo n=27 participants at risk Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes
Infections and infestations Upper respiratory tract infection	16.0% 4/25 • Number of events 4 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	28.0% 7/25 • Number of events 9 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.7% 2/26 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	23.1% 6/26 • Number of events 6 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Gastrointestinal disorders Nausea	12.0% 3/25 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	16.0% 4/25 • Number of events 4 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	11.5% 3/26 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	11.5% 3/26 • Number of events 4 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Metabolism and nutrition disorders Hypoglycaemia	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	12.0% 3/25 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.7% 2/26 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.4% 2/27 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Nervous system disorders Headache	16.0% 4/25 • Number of events 5 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.7% 2/26 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.7% 2/26 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Investigations Aspartate aminotransferace increased	12.0% 3/25 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	16.0% 4/25 • Number of events 4 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Investigations Alanine aminotransferace increased	12.0% 3/25 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	12.0% 3/25 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Respiratory, thoracic and mediastinal disorders Cough	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.7% 1/27 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Nervous system disorders Dizziness	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.7% 2/26 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.7% 2/26 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.7% 1/27 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	16.0% 4/25 • Number of events 4 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Blood and lymphatic system disorders Anemia	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Infections and infestations Influenza	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	12.0% 3/25 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.4% 2/27 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.4% 2/27 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/25 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	7.7% 2/26 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/27 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
Gastrointestinal disorders Diarrhoea	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	8.0% 2/25 • Number of events 2 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	4.0% 1/25 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.8% 1/26 • Number of events 1 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	0.00% 0/26 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).	3.7% 1/27 • Number of events 3 • All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).

Additional Information

Dung "Zung" Thai, MD, PhD

REMD Biotherapeutics, Inc

Phone: 415-225-9338

Email: zungthai@remdbio.com

Results disclosure agreements

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

Restriction type: LTE60