The Safety and Pharmacokinetics of ASKC200 in Osteoarthritic Knee Pain

NCT06614608 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: ASKC200-LC-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Efficacy:Change in the NRS score of weekly average of average daily pain intensity(WAADPI) From Baseline

  Day 19, Day 34

• Efficacy:Remission ratio of study knee according to NRS score

  Day 19, Day 34

• Efficacy:Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline

  Day 19, Day 34

• Efficacy:Change in patients clinical general impression (PCGI-C)

  Day 19, Day 34

• Efficacy:The use of acetaminophen

  34 days

Study Arms (2)

5% ASKC200

EXPERIMENTAL

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

1% ASKC200

EXPERIMENTAL

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

Interventions

5% ASKC200 DRUG

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.

5% ASKC200

1% ASKC200 DRUG

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.

1% ASKC200

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• 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;
• 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;
• Body mass index (BMI) ≤40.0 kg/m2.

You may not qualify if:

• 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;
• Patients with chronic pain in other parts of the body requiring long-term oral analgesic therapy, or those requiring combined treatment with systemic glucocorticoids;
• 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;
• The study knee has received intra-articular injection treatment (such as steroids or sodium hyaluronate, etc.) within 3 months before the first medication;
• Received physical therapy for study knee osteoarthritis (such as electrotherapy or acupuncture) within 3 months before the first medication;
• Used any capsaicin-containing product or non-steroidal anti-inflammatory drug on the knee within 2 weeks prior to the first administration;
• Have An open wound, skin erythema or edema, skin infection, or any other skin lesion in the study knee prior to initial administration;
• 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.

Sponsors & Collaborators

• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kexin Li

CONTACT

+86 10 85133642; Kexinli6202@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CN (1)