Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL 2-4 Osteoarthritic Knee (NCT NCT05419856)
NCT ID: NCT05419856
Last Updated: 2025-06-26
Results Overview
Number of participants with Adverse Events, serious AEs (SAEs), with abnormal Vital signs, abnormal ECG reading and abnormal Laboratory test results
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Day 1-Day 28
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
4P-004 w mg
4P-004 is administered once intraarticularly in the target knee joint Dose = w mg
|
4P-004 x mg
4P-004 is administered once intraarticularly in the target knee joint Dose = x mg
|
4P-004 y mg
4P-004 is administered once intraarticularly in the target knee joint Dose = y mg
|
4P-004 z mg
4P-004 is administered once intraarticularly in the target knee joint Dose = z mg
|
Placebo
Placebo: single intraarticular administration in the knee joint
|
|---|---|---|---|---|---|
|
Cohort 1
STARTED
|
6
|
0
|
0
|
0
|
2
|
|
Cohort 1
COMPLETED
|
6
|
0
|
0
|
0
|
2
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2
STARTED
|
0
|
6
|
0
|
0
|
2
|
|
Cohort 2
COMPLETED
|
0
|
6
|
0
|
0
|
2
|
|
Cohort 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3
STARTED
|
0
|
0
|
6
|
0
|
2
|
|
Cohort 3
COMPLETED
|
0
|
0
|
6
|
0
|
2
|
|
Cohort 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 4
STARTED
|
0
|
0
|
0
|
8
|
2
|
|
Cohort 4
COMPLETED
|
0
|
0
|
0
|
8
|
2
|
|
Cohort 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
4P-004 w mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint Dose = w mg
|
4P-004 x mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint Dose = x mg
|
4P-004 y mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint Dose = y mg
|
4P-004 z mg
n=8 Participants
4P-004: single intraarticular administration in the knee joint Dose = z mg
|
Placebo
n=8 Participants
Placebo: single intraarticular administration in the knee joint
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 6.9 • n=6 Participants
|
54.2 years
STANDARD_DEVIATION 5.3 • n=6 Participants
|
60.3 years
STANDARD_DEVIATION 8.5 • n=6 Participants
|
59.1 years
STANDARD_DEVIATION 59.5 • n=8 Participants
|
63.5 years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
60.1 years
STANDARD_DEVIATION 9.1 • n=34 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
19 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
29 kg/m2
STANDARD_DEVIATION 6.8 • n=6 Participants
|
28 kg/m2
STANDARD_DEVIATION 5.1 • n=6 Participants
|
28.5 kg/m2
STANDARD_DEVIATION 4.9 • n=6 Participants
|
25.5 kg/m2
STANDARD_DEVIATION 5 • n=8 Participants
|
29.5 kg/m2
STANDARD_DEVIATION 4.3 • n=8 Participants
|
28.1 kg/m2
STANDARD_DEVIATION 5.1 • n=34 Participants
|
|
Kellgren-Lawrence score
Kellgren-Lawrence 2
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
21 Participants
n=34 Participants
|
|
Kellgren-Lawrence score
Kellgren-Lawrence 3
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
11 Participants
n=34 Participants
|
|
Kellgren-Lawrence score
Kellgren-Lawrence 4
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=34 Participants
|
|
NRS
|
3.8 units on a scale
STANDARD_DEVIATION 2.3 • n=6 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 2.0 • n=6 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 2.6 • n=6 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 2.3 • n=8 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 2.4 • n=8 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 2.2 • n=34 Participants
|
PRIMARY outcome
Timeframe: Day 1-Day 28Number of participants with Adverse Events, serious AEs (SAEs), with abnormal Vital signs, abnormal ECG reading and abnormal Laboratory test results
Outcome measures
| Measure |
4P-004 w mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint Dose = w mg
|
4P-004 x mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint
Dose = x mg
|
4P-004 y mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint
Dose = y mg
|
4P-004 z mg
n=8 Participants
4P-004: single intraarticular administration in the knee joint
Dose = z mg
|
Placebo
n=8 Participants
Placebo: single intraarticular administration in the knee joint
|
|---|---|---|---|---|---|
|
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
SAE
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
Abnormal Laboratory Value
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
Abnormal ECG
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
TEAE
|
5 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
|
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
Abnormal Vital Sign
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 2Population: Placebo participant where not included in the PK population
Plasma concentration of liraglutide following a single IA injection at pre-injection (Time \[-4hours-0\]) and 2hours, 4hours, 8hours, 12hours, 16hours and 24-hours post injection.
Outcome measures
| Measure |
4P-004 w mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint Dose = w mg
|
4P-004 x mg
n=6 Participants
4P-004: single intraarticular administration in the knee joint
Dose = x mg
|
4P-004 y mg
n=5 Participants
4P-004: single intraarticular administration in the knee joint
Dose = y mg
|
4P-004 z mg
n=7 Participants
4P-004: single intraarticular administration in the knee joint
Dose = z mg
|
Placebo
Placebo: single intraarticular administration in the knee joint
|
|---|---|---|---|---|---|
|
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time 2 hours
|
3.6 ng/mL
Standard Deviation 1.1
|
7.2 ng/mL
Standard Deviation 4.2
|
58.1 ng/mL
Standard Deviation 38.8
|
24.6 ng/mL
Standard Deviation 15.7
|
—
|
|
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time 12 hours
|
7.1 ng/mL
Standard Deviation 3.1
|
24.5 ng/mL
Standard Deviation 12.9
|
122.2 ng/mL
Standard Deviation 69.2
|
67.2 ng/mL
Standard Deviation 24.7
|
—
|
|
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time 16 hours
|
6.4 ng/mL
Standard Deviation 2.9
|
23.5 ng/mL
Standard Deviation 12.0
|
113.6 ng/mL
Standard Deviation 61.8
|
63.8 ng/mL
Standard Deviation 25.4
|
—
|
|
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time 24 hours
|
5.0 ng/mL
Standard Deviation 2.4
|
20.0 ng/mL
Standard Deviation 9.4
|
95.2 ng/mL
Standard Deviation 52.1
|
53.6 ng/mL
Standard Deviation 25.4
|
—
|
|
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time [-4hours-0]
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time 4 hours
|
5.3 ng/mL
Standard Deviation 1.8
|
13.9 ng/mL
Standard Deviation 7.5
|
90.4 ng/mL
Standard Deviation 58.6
|
41.6 ng/mL
Standard Deviation 18.4
|
—
|
|
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time 8 hours
|
7.3 ng/mL
Standard Deviation 3.1
|
23.2 ng/mL
Standard Deviation 12.4
|
123.7 ng/mL
Standard Deviation 74.9
|
64.5 ng/mL
Standard Deviation 23.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 2, Day 8Serum and urine OA-related biomarkers (exploratory proteomic research of 4P-004 efficacy-related biomarkers) at Day 1 (Time \[-4-0\]hours, Time 8hours), Day 2 (Time 24hours) and Day 8.
Outcome measures
Outcome data not reported
Adverse Events
4P-004 w mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
4P-004 x mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
4P-004 y mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
4P-004 z mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4P-004 w mg
n=6 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = w mg
|
4P-004 x mg
n=6 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = x mg
|
4P-004 y mg
n=6 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = y mg
|
4P-004 z mg
n=8 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = z mg
|
Placebo
n=8 participants at risk
Placebo: single intraarticular administration in the knee joint
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
Other adverse events
| Measure |
4P-004 w mg
n=6 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = w mg
|
4P-004 x mg
n=6 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = x mg
|
4P-004 y mg
n=6 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = y mg
|
4P-004 z mg
n=8 participants at risk
4P-004: single intraarticular administration in the knee joint
Dose = z mg
|
Placebo
n=8 participants at risk
Placebo: single intraarticular administration in the knee joint
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
83.3%
5/6 • Number of events 8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
25.0%
2/8 • Number of events 3 • For each participant, adverse events were collected from screening until the End of study (D29)
|
25.0%
2/8 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
83.3%
5/6 • Number of events 5 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
25.0%
2/8 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Paraesthesia oral
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 5 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
33.3%
2/6 • Number of events 3 • For each participant, adverse events were collected from screening until the End of study (D29)
|
50.0%
4/8 • Number of events 4 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
33.3%
2/6 • Number of events 3 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
25.0%
2/8 • Number of events 4 • For each participant, adverse events were collected from screening until the End of study (D29)
|
25.0%
2/8 • Number of events 4 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
General disorders
Fatigue
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
General disorders
Injection site pain
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
33.3%
2/6 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
General disorders
Discomfort
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
General disorders
Injection site joint pain
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
2/6 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 2 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/6 • For each participant, adverse events were collected from screening until the End of study (D29)
|
0.00%
0/8 • For each participant, adverse events were collected from screening until the End of study (D29)
|
12.5%
1/8 • Number of events 1 • For each participant, adverse events were collected from screening until the End of study (D29)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The INSTITUTION and the INVESTIGATOR may not use any information other than publicly available information regarding the Study in any publicity and advertising without SPONSOR's prior written consent and ethics committee approval.
- Publication restrictions are in place
Restriction type: OTHER