Trial Outcomes & Findings for Safety and Pharmacokinetics Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) (NCT NCT02014051)
NCT ID: NCT02014051
Last Updated: 2022-11-21
Results Overview
Total Number Affected by Any Adverse Event (Details are presented in Adverse Event section)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Up to 18 weeks
Results posted on
2022-11-21
Participant Flow
Participant milestones
| Measure |
SyB C-1101 280 mg/Dose Group
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
All Participants
n=9 Participants
All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
|
|---|---|
|
Age, Customized
50-59 years
|
1 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 participants
n=5 Participants
|
|
Age, Customized
80- years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 weeksTotal Number Affected by Any Adverse Event (Details are presented in Adverse Event section)
Outcome measures
| Measure |
SyB C-1101 280 mg/Dose Group
n=3 Participants
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
n=6 Participants
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Adverse Events
|
3 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Up to 21 daysA DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 1. DLTs were also assessed in the Efficacy and Safety Assessment Committee. Criteria 1. Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhoea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhoea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs) 2. Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for \>= 4 days
Outcome measures
| Measure |
SyB C-1101 280 mg/Dose Group
n=3 Participants
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
n=6 Participants
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 60 weeksDefinition Complete remission (CR) Bone marrow: \<= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) \>= 11 g/dL, Platelets \>= 100×10\^9/L, Neutrophils \>= 1.0×10\^9/L, Blasts 0% Partial remission (PR) Same as CR except bone marrow blasts decreased by \>= 50% over pretreatment but still \> 5% Marrow CR Bone marrow: \<= 5% myeloblasts and decrease by \>= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR Stable disease Failure to achieve at least PR, but no evidence of progression for \> 8 weeks Disease progression Patients with: Less than 5% blasts: \>= 50% increase in blasts to \> 5% blasts 5%-10% blasts: \>= 50% increase to \> 10% blasts 10%-20% blasts: \>= 50% increase to \> 20% blasts 20%-30% blasts: \>= 50% increase to \> 30% blasts Any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by \>= 2 g/dL Transfusion dependence
Outcome measures
| Measure |
SyB C-1101 280 mg/Dose Group
n=3 Participants
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
n=6 Participants
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
CR
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
PR
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
Marrow CR
|
1 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
Stable disease (SD)
|
1 participants
|
1 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
Treatment failure
|
0 participants
|
0 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
Disease progression
|
0 participants
|
3 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
Not assessable
|
1 participants
|
2 participants
|
|
Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)
Remission rate
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 18 weeksDefinition Hematologic Improvement Erythrocyte (HI-E): Hgb increase by \>= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of \<= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation Hematologic Improvement Platelet (HI-P): Absolute increase of \>= 30×10\^9/L for patients starting with \> 20×10\^9/L platelets Increase from \< 20×10\^9/L to \> 20×10\^9/L and by at least 100% Hematologic Improvement Neutrophil (HI-N): At least 100% increase and an absolute increase \> 0.5×10\^9/L Progressive disease / Relapse: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by \>= 1.5 g/dL Transfusion dependence
Outcome measures
| Measure |
SyB C-1101 280 mg/Dose Group
n=3 Participants
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
n=6 Participants
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)
HI-E
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)
HI-P
|
1 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)
HI-N
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)
Progressive disease
|
0 participants
|
1 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)
Relapse
|
0 participants
|
0 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)
Not assessable
|
2 participants
|
5 participants
|
|
Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)
Hematologic improvement rate
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 weeksMTD was investigated with an index of DLT
Outcome measures
| Measure |
SyB C-1101 280 mg/Dose Group
n=9 Participants
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA participants
MTD was not reached
|
—
|
Adverse Events
SyB C-1101 280 mg/Dose Group
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
SyB C-1101 560 mg/Dose Group
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SyB C-1101 280 mg/Dose Group
n=3 participants at risk
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
n=6 participants at risk
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Psychiatric disorders
Delirium
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
Other adverse events
| Measure |
SyB C-1101 280 mg/Dose Group
n=3 participants at risk
Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
SyB C-1101 560 mg/Dose Group
n=6 participants at risk
Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics.
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
General disorders
Thirst
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
33.3%
2/6 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
33.3%
2/6 • Number of events 3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
CD4 lymphocytes decreased
|
33.3%
1/3 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 2 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
1/3 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
0.00%
0/6 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks for each dosing cohort
All participants who received at least one dose of SyB C-1101.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place