Clinical trial NCT04473859: Study to Evaluate the Safety of FSR Peptide Versus Placebo Following Punch Biopsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wound Heal
Lead sponsor: Xequel Bio, Inc.
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Frequency of adverse events
timeFrame: Time of consent to day 28
Secondary outcomes:
measure: Time to healing
timeFrame: Up to 28 days
measure: Presence of hypertrophic granulation tissue
timeFrame: Up to 28 days
measure: Clinical General Impression scale on the evolution of the wound.
timeFrame: Up to 28 days
measure: Wound height
timeFrame: day 28
measure: Wound pliability
timeFrame: day 28
measure: Histopathological evaluation of the area of the scar tissue
timeFrame: day 28
measure: Histopathological evaluation of the epidermal involution
timeFrame: day 28
measure: Histopathological evaluation of the rete pegs
timeFrame: day 28
measure: Histopathological evaluation of the area of granulation tissue
timeFrame: day 28
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
facility: Swiss Pharma Contract Ltd
Study officials:
affiliation: CEO
name: Gautam Ghatnekar
role: PRINCIPAL_INVESTIGATOR
References: