Trial Outcomes & Findings for Single-Dose Administration Trial of TLC599 in Osteoarthritis of the Knee (NCT NCT02803307)
NCT ID: NCT02803307
Last Updated: 2022-05-06
Results Overview
Number of participants with at least one TEAE
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
up to 12 weeks after dosing
Results posted on
2022-05-06
Participant Flow
Participant milestones
| Measure |
6 mg TLC599
6 mg DSP with 50 μmol PL
TLC599: Single dose via intra-articular injection
|
12 mg TLC599
12 mg DSP with 100 μmol PL
TLC599: Single dose via intra-articular injection
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-Dose Administration Trial of TLC599 in Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
6 mg TLC599
n=20 Participants
6 mg DSP with 50 μmol PL
TLC599: Single dose via intra-articular injection
|
12 mg TLC599
n=20 Participants
12 mg DSP with 100 μmol PL
TLC599: Single dose via intra-articular injection
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.70 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
68.10 years
STANDARD_DEVIATION 8.03 • n=7 Participants
|
67.40 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Kellgren-Lawrence grade
Grade 0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Kellgren-Lawrence grade
Grade 1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Kellgren-Lawrence grade
Grade 2
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Kellgren-Lawrence grade
Grade 3
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Kellgren-Lawrence grade
Grade 4
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeks after dosingNumber of participants with at least one TEAE
Outcome measures
| Measure |
6 mg TLC599
n=20 Participants
6 mg DSP with 50 μmol PL
TLC599: Single dose via intra-articular injection
|
12 mg TLC599
n=20 Participants
12 mg DSP with 100 μmol PL
TLC599: Single dose via intra-articular injection
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
9 Participants
|
9 Participants
|
Adverse Events
6 mg TLC599
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
12 mg TLC599
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
6 mg TLC599
n=20 participants at risk
6 mg DSP with 50 μmol PL
TLC599: Single dose via intra-articular injection
|
12 mg TLC599
n=20 participants at risk
12 mg DSP with 100 μmol PL
TLC599: Single dose via intra-articular injection
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Cardiac disorders
Arrhythmia
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
General disorders
Pyrexia
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • 12 weeks
|
15.0%
3/20 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place