CompletedNCT04473859Updated Jul 20, 2020

Study to Evaluate the Safety of FSR Peptide Versus Placebo Following Punch Biopsy

A Phase 1 interventional study of FSR Peptide 20μM and FSR Peptide 50μM in Wound Heal, sponsored by Xequel Bio, Inc.. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-20.

Sponsored by Xequel Bio, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Apr 2009, 17 years 5 months ago, and no results have been posted to the registry.
Registered 12 years 4 months after the study started (first participant enrolled Mar 2008, registered Jul 2020).

Phase: Phase 1
Study type: Interventional
Enrollment: 49
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

The purposes of this study is to test the safety of the study drug (FSR peptide) after a punch biopsy in healthy subjects.

Conditions studied

Wound Heal

In context

Lead sponsor

Xequel Bio, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 49 participants (actual)

Study arms

Experimental
FSR Peptide 20 μM
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.
Drug: FSR Peptide 20μM · Drug: Placebo
Experimental
FSR peptide 50 μM
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.
Drug: FSR Peptide 50μM · Drug: Placebo
Experimental
FSR peptide 100 μM
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.
Drug: FSR Peptide 100μM · Drug: Placebo
Experimental
FSR peptide 200 μM
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.
Drug: FSR Peptide 200μM · Drug: Placebo
Placebo comparator
Placebo only
Each subject will have two punch biopsies. Placebo will be applied to both punch biopsies.
Drug: Placebo

Interventions

DrugFSR Peptide 20μM
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
DrugFSR Peptide 50μM
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
DrugFSR Peptide 100μM
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
DrugFSR Peptide 200μM
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
DrugPlacebo
Administered immediately after punch-biopsy and 24 hours after punch biopsy.

What researchers measure

Primary outcomes

Frequency of adverse events
Time frame: Time of consent to day 28

Secondary outcomes

Time to healing
The wound was clinically evaluated as healed or not healed.
Time frame: 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.
Time frame: 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
Time frame: 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 1. Hypopigmentation 2. Hyperpigmentation Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body 1. Pink 2. Red 3. Purple
Time frame: 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 1. Hypopigmentation 2. Hyperpigmentation Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body 1. Pink 2. Red 3. Purple
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: day 28

Study locations

1 site

Swiss Pharma Contract Ltd
Allschwil, CH-4123, Switzerland

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04473859
Lead sponsor: Xequel Bio, Inc.
Responsible party: Sponsor
First posted: Jul 16, 2020
Start date: Mar 6, 2008
Primary completion: Apr 28, 2009
Completion: Apr 28, 2009
Last update: Jul 20, 2020

Study contacts

Gautam Ghatnekar

principal investigator · CEO

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Xequel Bio, Inc.

Start the discussion