The Safety and Pharmacokinetics of ASKC200 in Osteoarthritic Knee Pain (ASKC200)

A Multi-Center, Randomized, Double-blind Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASKC200 in Patients with Osteoarthritic Knee Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Osteoarthritis, Knee
• Intervention / Treatment: Drug: 5% ASKC200; Drug: 1% ASKC200

Detailed Description

Subjects will be randomized to one of the two Arms in this study: 5% ASKC200 or 1% ASKC200. All subjects will receive 4 consecutive days of treatment and will then be followed up until the Day 34 visit.

The NRS score of weekly average of average daily pain intensity (WAADPI) of the study knee should ≥ 5 and the NRS score of WAADPI of the contralateral knee should < 4 at screening.

Data will be collected from Day 1 through Day 5 and then again on Days 19 and 34 for efficacy, tolerability, and safety measures.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kexin Li; Phone Number: +86 10 85133642; Email: Kexinli6202@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Hospital
      • Contact: Kexin Li; Phone Number: +86 10 85133642; Email: Kexinli6202@163.com
      • Contact: Luwei Han; Phone Number: +86 25 86090621; Email: hanluwei@ask-pharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Sign informed consent prior to any inspection and evaluation, and understand and follow test requirements;
2. Age 40-75 years old (including boundary value) at the time of signing the informed consent, gender is not limited;
3. Primary knee osteoarthritis was confirmed by clinical and imaging examination;
4. Knee osteoarthritis pain history ≥6 months;
5. Tibial joint X-ray within 3 months prior to drug administration showed that the tibiofemoral joint of the target knee was graded Kellgren-Lawrence II or III;
6. Before the first medication, the WAADPI NRS score of the study knee was ≥5, and the WAADPI NRS score of the contralateral knee was <4;
7. Be willing to discontinue the use of nonsteroidal anti-inflammatory drugs, acetaminophen, and other pain medications, and only use the acetaminophen provided in the study for emergency treatment of knee osteoarthritis pain during the study period;
8. Body mass index (BMI) ≤40.0 kg/m2.

Exclusion Criteria:

1. Secondary arthritis caused by other causes;
2. The study knee has other knee pathologic findings confirmed by clinical evaluation or imaging
3. There are other conditions that can cause study knee pain or other physical pain;
4. Other medications for osteoarthritis were used within 1 week prior to the first dose;
5. Patients with chronic pain in other parts of the body requiring long-term oral analgesic therapy, or those requiring combined treatment with systemic glucocorticoids;
6. Open knee injury or knee surgery occurred in the study knee within 6 months before the first medication; Or have had any major surgical procedures within 3 months prior to the first medication;
7. The study knee has received intra-articular injection treatment (such as steroids or sodium hyaluronate, etc.) within 3 months before the first medication;
8. Received physical therapy for study knee osteoarthritis (such as electrotherapy or acupuncture) within 3 months before the first medication;
9. Used any capsaicin-containing product or non-steroidal anti-inflammatory drug on the knee within 2 weeks prior to the first administration;
10. Have An open wound, skin erythema or edema, skin infection, or any other skin lesion in the study knee prior to initial administration;
11. A history of alcohol or drug dependence within 12 months prior to the first administration or a positive urine drug test during the screening period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5% ASKC200; A single dose will be topically applied to study knees for 60 minutes on Visit 1 on Day 1, Day 2, Day 3, and Day 4.	Drug: 5% ASKC200; 5% ASKC200 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.
Experimental: 1% ASKC200; A single dose will be topically applied to study knees for 60 minutes on Visit 1 on Day 1, Day 2, Day 3, and Day 4.	Drug: 1% ASKC200; 1% ASKC200 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of1% for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety:Incidence of adverse events（AEs）	All adverse medical events occurring after the subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily have a causal relationship with the investigational drug.	34 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy:Change in the NRS score of weekly average of average daily pain intensity(WAADPI) From Baseline	The average amount of pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.	Day 19, Day 34
Efficacy:Remission ratio of study knee according to NRS score	The average amount of pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.	Day 19, Day 34
Efficacy:The use of acetaminophen	Subjects will record their administration of acetaminophen . The number of days the subjects use acetaminophen and the proportion of subjects who use acetaminophen will be counted.	34 days
Maximum Observed Plasma Concentration (Cmax) for ASKC200		Day1-Day5
Time of First Occurrence of Cmax (Tmax) for ASKC200		Day1-Day5
Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours (AUC24) for for ASKC200		Day1-Day5
Efficacy:Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline	The WOMAC Index is a questionnaire used to assess health status and health outcomes in KOA. The questionnaire contains 24 questions（0-10） on pain, stiffness and physiology, will ask participants to complete the WOMAC questionnaire considering their symptoms in the past 48 hours.Higher scores indicate more pain.	Day 19, Day 34
Efficacy:Change in patients clinical general impression (PCGI-C)	The change in patients clinical general impression as reported by the subject using a 0 - 7 scale (PCGI-C).Higher scores indicate worse state of pain.	Day 19, Day 34

Collaborators and Investigators

• Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ASKC200-LC-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No