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

NCT04473859 | Completed Phase 1 FDA Drug

• 1 other identifier: ACT1-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events

  Time of consent to day 28

Secondary Outcomes (9)

• Time to healing

  Up to 28 days

• Presence of hypertrophic granulation tissue

  Up to 28 days

• Clinical General Impression scale on the evolution of the wound.

  Up to 28 days

• Wound height

  day 28

• Wound pliability

  day 28

Study Arms (5)

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.

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.

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.

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.

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.

Drug: Placebo

Interventions

FSR Peptide 20μM DRUG

Administered immediately after punch-biopsy and 24 hours after punch biopsy.

FSR Peptide 20 μM

FSR Peptide 50μM DRUG

Administered immediately after punch-biopsy and 24 hours after punch biopsy.

FSR peptide 50 μM

FSR Peptide 100μM DRUG

Administered immediately after punch-biopsy and 24 hours after punch biopsy.

FSR peptide 100 μM

FSR Peptide 200μM DRUG

Administered immediately after punch-biopsy and 24 hours after punch biopsy.

FSR peptide 200 μM

Placebo DRUG

Administered immediately after punch-biopsy and 24 hours after punch biopsy.

FSR Peptide 20 μM; FSR peptide 100 μM; FSR peptide 200 μM; FSR peptide 50 μM; Placebo only

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Xequel Bio, Inc.: lead

Study Sites (1)

Swiss Pharma Contract Ltd

Allschwil, CH-4123, Switzerland

Location

Study Officials

• Gautam Ghatnekar

  CEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 16, 2020
• Study Start: March 6, 2008
• Primary Completion: April 28, 2009
• Study Completion: April 28, 2009
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

CH (1)