Wound HealPhase 1NCT04473859
Study to Evaluate the Safety of FSR Peptide Versus Placebo Following Punch Biopsy
A Phase 1 study testing FSR Peptide 20μM, FSR Peptide 50μM and FSR Peptide 100μM in people with Wound Heal, run by Xequel Bio, Inc. at 1 site in Switzerland.
Trial summary
The purposes of this study is to test the safety of the study drug (FSR peptide) after a punch biopsy in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- FSR Peptide 20μM, FSR Peptide 50μM and FSR Peptide 100μM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Mar 2008to 28 Apr 2009
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female healthy subjects, 18-45 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Female subjects must have been surgically sterilized at least six months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. OR: Postmenopausal women must have no regular menstrual bleeding for at least two years prior to inclusion. Menopause was to be confirmed by a plasma 17β-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L.
- Normal sitting blood pressure and pulse rate , i.e.: BP: 100 - 140 mm Hg systolic, 50 - 90 mm Hg diastolic and pulse rate: 45 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes resting in a sitting position.
- Subject body mass index between 18 and 30 kg/m2
- Ability to communicate well with the investigator and comply with the requirements of the entire study.
- The subject has given his written consent to participate in the study.
Who cannot join
- History of serious adverse reactions or hypersensitivity to any drug.
- Presence or history of any allergy requiring acute or chronic treatment (seasonal) allergic rhinitis which requires no treatment may be tolerated).
- History of alcohol or drug abuse in the last 3 years.
- Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
- Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug or anticipated need for any concomitant medication during the study.
- Participation in a clinical trial during the previous 4 weeks, i.e. from completion of the previous trial to the planned first administration of the current trial.
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- Loss of 500 ml blood or more during the 3 month period before the study, e.g. as a donor.
- Existence of any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
- Symptoms of a significant somatic or mental illness in the two week period preceding drug administration.
- History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
- Positive results from the HIV serology.
- Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation. Serum albumin below 3.5 g/l (Note to File no. 8 states that the correct albumin value is below 35g/l) precludes study inclusion in any case.
- History of serious mental disorders.
- Positive results of the drug screening.
- History or clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurologic or other disease.
- Presence of any active skin pathology including e.g., acne, acute sunburn, inflammatory skin disease.
- Presence of any open wounds or infection on the same arm.
- History of skin disorders e.g. atopic eczema or psoriasis or keloid reaction(s) Any condition that constitutes a contraindication to minor surgical procedures (such as bleeding disorders) or that obliges to the use of prophylactic antibiotics (such as mitral valve prolapse) or other comedications for the performance of minor surgical procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Single Center, Controlled Study to Evaluate the Safety and Tolerability of FSR Peptide Versus Placebo Following Punch Biopsy in Adult Healthy Volunteers
The purposes of this study is to test the safety of the study drug (FSR peptide) after a punch biopsy in healthy subjects.
- Conditions
- Wound Heal
- Being tested
- FSR Peptide 20μM, FSR Peptide 50μM, FSR Peptide 100μM, FSR Peptide 200μM, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSR Peptide 20μMDrug
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
FSR Peptide 50μMDrug
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
FSR Peptide 100μMDrug
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
FSR Peptide 200μMDrug
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
PlaceboDrug
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
| Study group | Role | What they receive |
|---|---|---|
| FSR Peptide 20 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. Receives: Drug: FSR Peptide 20μM; Drug: Placebo |
| FSR peptide 50 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. Receives: Drug: FSR Peptide 50μM; Drug: Placebo |
| FSR peptide 100 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. Receives: Drug: FSR Peptide 100μM; Drug: Placebo |
| FSR peptide 200 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. Receives: Drug: FSR Peptide 200μM; Drug: Placebo |
| Placebo only | Placebo comparator | Each subject will have two punch biopsies. Placebo will be applied to both punch biopsies. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: Time of consent to day 28
Secondary outcomes (9)
Time to healing
The wound was clinically evaluated as healed or not healed.
Measured: Up to 28 days
Presence of hypertrophic granulation tissue
Clinically assessed as present or not present. To qualify as present, there should be at least 3 mm granulation tissue protruding above the edge of the wound at any point of its perimeter.
Measured: Up to 28 days
Clinical General Impression scale on the evolution of the wound.
Scale of 1-5: 1- Very bad; 2- Bad; 3- Fair; 4- Good; 5- Very Good
Measured: Up to 28 days
Wound height
Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score.
Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body
- Hypopigmentation
- Hyperpigmentation
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body
- Pink
- Red
- Purple
Measured: day 28
Wound pliability
Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score.
Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body
- Hypopigmentation
- Hyperpigmentation
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body
- Pink
- Red
- Purple
Measured: day 28
Histopathological evaluation of the area of the scar tissue
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Measured: day 28
Histopathological evaluation of the epidermal involution
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Measured: day 28
Histopathological evaluation of the rete pegs
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Measured: day 28
Histopathological evaluation of the area of granulation tissue
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start6 Mar 2008
- Primary completion28 Apr 2009
- Study completion28 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xequel Bio, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautam Ghatnekar, Principal investigator, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473859
- Sponsor's protocol ID
- ACT1-01
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Single Center, Controlled Study to Evaluate the Safety and Tolerability of FSR Peptide Versus Placebo Following Punch Biopsy in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04473859
- Acronym / sponsor ID
- ACT1-01
- Conditions
- Wound Heal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Xequel Bio, Inc.University, hospital or other
- Study start
- 6 Mar 2008 (actual)
- Primary completion
- 28 Apr 2009 (actual)
- Study completion
- 28 Apr 2009 (actual)
- First posted
- 16 Jul 2020 (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.
The purposes of this study is to test the safety of the study drug (FSR peptide) after a punch biopsy in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FSR Peptide 20 μM | Experimental | Drug: FSR Peptide 20μM, Drug: PlaceboEach subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
| FSR peptide 50 μM | Experimental | Drug: FSR Peptide 50μM, Drug: PlaceboEach subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
| FSR peptide 100 μM | Experimental | Drug: FSR Peptide 100μM, Drug: PlaceboEach subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
| FSR peptide 200 μM | Experimental | Drug: FSR Peptide 200μM, Drug: PlaceboEach subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
| Placebo only | Placebo comparator | Drug: PlaceboEach subject will have two punch biopsies. Placebo will be applied to both punch biopsies. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female healthy subjects, 18-45 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Female subjects must have been surgically sterilized at least six months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. OR: Postmenopausal women must have no regular menstrual bleeding for at least two years prior to inclusion. Menopause was to be confirmed by a plasma 17β-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L.
- Normal sitting blood pressure and pulse rate , i.e.: BP: 100 - 140 mm Hg systolic, 50 - 90 mm Hg diastolic and pulse rate: 45 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes resting in a sitting position.
- Subject body mass index between 18 and 30 kg/m2
- Ability to communicate well with the investigator and comply with the requirements of the entire study.
Key exclusion criteria (18 listed)
- History of serious adverse reactions or hypersensitivity to any drug.
- Presence or history of any allergy requiring acute or chronic treatment (seasonal) allergic rhinitis which requires no treatment may be tolerated).
- History of alcohol or drug abuse in the last 3 years.
- Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
- Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug or anticipated need for any concomitant medication during the study.
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 |
|---|---|---|
| FSR Peptide 20μMAdministered immediately after punch-biopsy and 24 hours after punch biopsy. | Drug | FSR Peptide 20 μM |
| FSR Peptide 50μMAdministered immediately after punch-biopsy and 24 hours after punch biopsy. | Drug | FSR peptide 50 μM |
| FSR Peptide 100μMAdministered immediately after punch-biopsy and 24 hours after punch biopsy. | Drug | FSR peptide 100 μM |
| FSR Peptide 200μMAdministered immediately after punch-biopsy and 24 hours after punch biopsy. | Drug | FSR peptide 200 μM |
| PlaceboAdministered immediately after punch-biopsy and 24 hours after punch biopsy. | Drug | FSR Peptide 20 μM, FSR peptide 100 μM, FSR peptide 200 μM, FSR peptide 50 μM, Placebo only |
Primary outcome
Frequency of adverse events
Time frame: Time of consent to day 28
9 secondary outcomes
Time to healing
Time frame: Up to 28 days
Presence of hypertrophic granulation tissue
Time frame: Up to 28 days
Clinical General Impression scale on the evolution of the wound.
Time frame: Up to 28 days
Wound height
Time frame: day 28
Wound pliability
Time frame: day 28
Histopathological evaluation of the area of the scar tissue
Time frame: day 28
Histopathological evaluation of the epidermal involution
Time frame: day 28
Histopathological evaluation of the rete pegs
Time frame: day 28
Histopathological evaluation of the area of granulation tissue
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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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.
Gautam Ghatnekar principal investigator
CEO
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 FSR Peptide 20μM, FSR Peptide 50μM and FSR Peptide 100μM in people with Wound Heal, run by Xequel Bio, Inc. at 1 site in Switzerland.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 20 Jul 2020. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (time frame: Time of consent to day 28). 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 20 Jul 2020.