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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The goal of this clinical trial is to investigate GHK and GHK-Cu blood levels pre- and post-intervention in healthy adults, and to investigate the efficacy of X39 patch on GHK and GHK-Cu blood levels in healthy adults compared to a placebo. The main questions it aims to answer are:
Participants will be asked to complete a questionnaire and use the X39 patch or placebo patch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X39 Patch | Experimental | Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. |
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| Placebo patch | Placebo Comparator | Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X39 Patch | Device | Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GHK levels from baseline to Day 8 | Part 1. Change in GHK levels from baseline to Day 8 | Baseline (Day 0) to Day 8 |
| Change in GHK levels from baseline to Day 8 between the X39 patch and placebo | Part 2. Change in GHK levels from baseline to Day 8 between the X39 patch and placebo | Baseline (Day 0) to Day 8 |
| Change in GHK-Cu levels from baseline to Day 8 | Part 1. Change in GHK-Cu levels from baseline to Day 8 | Baseline (Day 0) to Day 8 |
| Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo | Part 2. Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo | Baseline (Day 0) to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GHK levels from baseline to Day 2 | Part 1. Change in GHK levels from baseline to Day 2 | Baseline (Day 0) to Day 2 |
| Quality of Life, RAND SF-36 | Part 1. Change in quality of life from baseline to Days 2 and 8, as assessed by the RAND 36-item Short-Form Health Survey (RAND SF-36) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Day 0 to Day 8 |
| Clinically relevant changes in blood pressure after supplementation | Clinically relevant changes in blood pressure (mmHg) after supplementation |
Inclusion Criteria:
Males and females 35 years and older
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Agrees to refrain from vigorous physical activity, alcohol consumption, and taking NSAIDs 24 hours prior to study visits
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Willingness to complete questionnaires, diaries and to complete all clinic visits
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewis, PhD | Contact | +248 1-226-242-4551 | elewis@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N5Y 5V6 | Canada |
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Part 1: Single-arm, open-label & Part 2: Randomized, double-blind, placebo controlled, parallel
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Part 1: Single-arm, open-label & Part 2: Randomized, double-blind, placebo controlled, parallel
|
| Placebo Patch | Device | Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. |
|
| Baseline (Day 0) to Day 8 |
| Change in GHK levels from baseline to Day 2 between the X39 patch and placebo | Part 2. Change in GHK levels from baseline to Day 2 between the X39 patch and placebo | Baseline (day 0) to Day 2 |
| Change in Quality of Life from Baseline to Days 2 and 8 (RAND 36-Item Short Form Health Survey - RAND SF-36) Between X39 Patch and Placebo | Part 2. Change in quality of life from baseline to Days 2 and 8, as assessed by the RAND 36-Item Short Form Health Survey (RAND SF-36), between the X39 patch and placebo. This questionnaire measures nine scales including physical functioning, role limitations due to physical health, role limitations due to emotional health, pain, general health, energy/fatigue, social functioning, emotional well-being, and health transition. The scores range from 0 to 100 where higher scores indicate a better state of health. | Baseline (day 0) to Day 8 |
| Change in GHK-Cu levels from baseline to Day 2 | Part 1. Change in GHK-Cu levels from baseline to Day 2 | Baseline (Day 0) to Day 2 |
| Change in GHK-Cu levels from baseline to Day 2 between the X39 patch and placebo | Part 2. Change in GHK-Cu levels from baseline to Day 2 between the X39 patch and placebo | Baseline (day 0) to Day 2 |
| Day 0 to Day 8 |
| Clinically relevant changes in sodium | Clinically relevant changes in sodium (mmol/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in heart rate after supplementation | Clinically relevant changes in heart rate (beats per minute) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in potassium | Clinically relevant changes in potassium (mmol/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in chloride | Clinically relevant changes in chloride (mmol/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in estimated glomerular filtration rate | Clinically relevant changes in estimated glomerular filtration rate (mL/min/1.73 m^2) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in glucose | Clinically relevant changes in glucose (mmol/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in creatinine | Clinically relevant changes in creatinine (micromole/litre) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in aspartate aminotransferase | Clinically relevant changes in aspartate aminotransferase (U/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in alanine aminotransferase | Clinically relevant changes in alanine aminotransferase (U/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in alkaline phosphatase | Clinically relevant changes in alkaline phosphatase (U/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in bilirubin | Clinically relevant changes in bilirubin (micromole/litre) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in red blood cell count | Clinically relevant changes in red blood cell count (x 10^12/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in white blood cell count | Clinically relevant changes in white blood cell count (x 10^9/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in platelet count | Clinically relevant changes in platelet count (x 10^9/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in hemoglobin | Clinically relevant changes in hemoglobin (g/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in hematocrit | Clinically relevant changes in hematocrit (L/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in red blood cell indices (MCV) | Clinically relevant changes in MCV (fL) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in red blood cell indices (MCH) | Clinically relevant changes in MCH (pg) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in red blood cell indices (MCHC) | Clinically relevant changes in MCHC (g/L) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in red blood cell indices (MPV) | Clinically relevant changes in MPV (fL) after supplementation | Day 0 to Day 8 |
| Clinically relevant changes in RDW | Clinically relevant changes in RDW (%) after supplementation | Day 0 to Day 8 |