Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
| Group | Value (participants) |
|---|---|
| 4P-004 w mg | 5 |
| 4P-004 x mg | 5 |
| 4P-004 y mg | 5 |
| 4P-004 z mg | 6 |
| Placebo | 6 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataShort name LASARE
Belgium
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase I study is a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending dose of IA 4P-004 in participants, * Between 18 and 80 years of age, * with target knee OA stage KL 2-4 A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).
Experimental
4P-004 w mg
4P-004 is administered once intraarticularly in the target knee joint Dose = w mg
Experimental
4P-004 x mg
4P-004 is administered once intraarticularly in the target knee joint Dose = x mg
Experimental
4P-004 y mg
4P-004 is administered once intraarticularly in the target knee joint Dose = y mg
Experimental
4P-004 z mg
4P-004 is administered once intraarticularly in the target knee joint Dose = z mg
Placebo comparator
Placebo
Placebo is administered once intraarticularly in the target knee joint
Outcomes the sponsor listed as primary.
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
Time frame · Day 1-Day 28
Number of participants with Adverse Events, serious AEs (SAEs), with abnormal Vital signs, abnormal ECG reading and abnormal Laboratory test results
To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA
Time frame · Day 1 to Day 2
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| 4P-004 w mg | 5 |
| 4P-004 x mg | 5 |
| 4P-004 y mg | 5 |
| 4P-004 z mg | 6 |
| Placebo | 6 |
| Group | Value (ng/mL) | Spread |
|---|---|---|
| 4P-004 w mg | 0 | 0 |
| 4P-004 x mg | 0 | 0 |
| 4P-004 y mg | 0 | 0 |
| 4P-004 z mg | 0 | 0 |
| Placebo | not posted | – |
| Group | Value |
|---|
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 4P-004 w mg4P-004: single intraarticular administration in the knee joint Dose = w mg | 0 / 6 | 0 / 6 | 5 / 6 |
| 4P-004 x mg4P-004: single intraarticular administration in the knee joint Dose = x mg | 0 / 6 | 0 / 6 | 5 / 6 |
| 4P-004 y mg4P-004: single intraarticular administration in the knee joint Dose = y mg | 0 / 6 | 1 / 6 | 5 / 6 |
| 4P-004 z mg4P-004: single intraarticular administration in the knee joint Dose = z mg | 0 / 8 | 0 / 8 | 6 / 8 |
| PlaceboPlacebo: single intraarticular administration in the knee joint | 0 / 8 | 0 / 8 | 6 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Animal study · 2022
Meurot et al. 2022Scientific reportscited by 131
PMID 35091584PMC8799666DOI 10.1038/s41598-022-05323-7PUB-35091584
Who could join, as posted.
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