Study S002286

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of 4P004 Versus Placebo Injected in the Target Knee of Patients With Grade 2 to 4 Osteoarthritis on the Kellgren and Lawrence Severity Index

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05419856
Acronym: LASARE
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 34
Start: 2022-08-09
Primary completion: 2023-10-31
Lead sponsor: 4Moving Biotech
Conditions: Knee Osteoarthritis
Interventions: DRUG:4P-004; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA. [Day 1-Day 28]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0007147	Liraglutide, a glucagon-like peptide 1 receptor agonist, exerts analgesic, anti-inflammatory and anti-degradative actions in osteoarthritis. Meurot C, Scientific reports	2022	Preclinical	PMID 35091584 DOI	registry reference BACKGROUND:35091584