Osteoarthritis, KneePhase 1ASKC200NCT06614608
The Safety and Pharmacokinetics of ASKC200 in Osteoarthritic Knee Pain
A Phase 1 study testing 5% ASKC200 and 1% ASKC200 in people with Osteoarthritis, Knee and Pain, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- 5% ASKC200 and 1% ASKC200
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Oct 2024to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Hospital
Beijing, Beijing Municipality, 100730
Kexin Li, +86 10 85133642, Kexinli6202@163.com
Luwei Han, +86 25 86090621, hanluwei@ask-pharm.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- 5% ASKC200, 1% ASKC200
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% ASKC200Drug
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.
1% ASKC200Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 1% ASKC200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 34 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: Day 19, Day 34
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.
Measured: 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.
Measured: 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.
Measured: 34 days
Maximum Observed Plasma Concentration (Cmax) for ASKC200
Measured: Day1-Day5
Time of First Occurrence of Cmax (Tmax) for ASKC200
Measured: Day1-Day5
Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours (AUC24) for for ASKC200
Measured: Day1-Day5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614608
- Sponsor's protocol ID
- ASKC200-LC-102
- Acronym
- ASKC200
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06614608
- Acronym / sponsor ID
- ASKC200 / ASKC200-LC-102
- Conditions
- Osteoarthritis, Knee, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% ASKC200 | Experimental | Drug: 5% ASKC200A 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. |
| 1% ASKC200 | Experimental | Drug: 1% ASKC200A 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% ASKC2005% 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. | Drug | 5% ASKC200 |
| 1% ASKC2001% 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. | Drug | 1% ASKC200 |
Primary outcome
Safety:Incidence of adverse events（AEs）
Time frame: 34 days
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.
8 secondary outcomes
Efficacy:Change in the NRS score of weekly average of average daily pain intensity(WAADPI) From Baseline
Time frame: Day 19, Day 34
Efficacy:Remission ratio of study knee according to NRS score
Time frame: Day 19, Day 34
Efficacy:Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline
Time frame: Day 19, Day 34
Efficacy:Change in patients clinical general impression (PCGI-C)
Time frame: Day 19, Day 34
Efficacy:The use of acetaminophen
Time frame: 34 days
Maximum Observed Plasma Concentration (Cmax) for ASKC200
Time frame: Day1-Day5
Time of First Occurrence of Cmax (Tmax) for ASKC200
Time frame: Day1-Day5
Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours (AUC24) for for ASKC200
Time frame: Day1-Day5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5% ASKC200 and 1% ASKC200 in people with Osteoarthritis, Knee and Pain, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kexin Li (+86 10 85133642, Kexinli6202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety:Incidence of adverse events（AEs） (time frame: 34 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.