The Safety and Pharmacokinetics of ASKC200 in Osteoarthritic Knee Pain
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorJiangsu Aosaikang Pharmaceutical Co., Ltd.
About this trial
This is a multi-center, randomized, double-blind clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKC200 in subjects with OA of the knees and determine the phase II recommended dose. Assigned doses will be applied for 60 minutes on each of four consecutive days.
Eligibility criteria
Qualifiers
Sign informed consent prior to any inspection and evaluation, and understand and follow test requirements;
Age 40-75 years old (including boundary value) at the time of signing the informed consent, gender is not limited;
Primary knee osteoarthritis was confirmed by clinical and imaging examination;
Knee osteoarthritis pain history ≥6 months;
Disqualifiers
Secondary arthritis caused by other causes;
The study knee has other knee pathologic findings confirmed by clinical evaluation or imaging
There are other conditions that can cause study knee pain or other physical pain;
Other medications for osteoarthritis were used within 1 week prior to the first dose;
Trial design
Treatments tested in this trial
- 5% ASKC200
- 1% ASKC200
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov