Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis

NCT03960450 | Completed Phase 1 FDA Drug

• 1 other identifier: BOS-475-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This study was conducted to evaluate the safety and tolerability of BOS-475 following single and repeat topical administration to healthy participants (Part A), and to evaluate the safety and tolerability of 42-day repeat topical administration of BOS-475 to participants with plaque psoriasis (Part B).

Conditions

Psoriasis

Keywords

Psoriasis; BOS-475

Outcome Measures

Primary Outcomes (5)

• Parts A and B: Number of participants with any adverse event (AEs) and any serious adverse event (SAE)

  up to Week 8

• Parts A and B: Change from baseline in the application site tolerability assessment score

  Change from baseline in the application site tolerability assessment score was measured using the Topical Application Site Tolerability Assessment Scale (5-point scale ranging from 0-no irritation to 4-very severe irritation).

  up to Week 8

• Parts A and B: Number of participants with any clinically significant change from baseline in clinical laboratory parameter values

  up to Week 8

• Parts A and B: Number of participants with any clinically significant change from baseline in vital sign values

  up to Week 8

• Parts A and B: Number of participants with any clinically significant change from baseline in electrocardiogram (ECG) findings

  up to Week 8

Secondary Outcomes (2)

• Part A: Plasma concentration of BOS-475

  Day 1, predose and 1, 2, 4, 8, 24, 48, and 72 hours postdose; Days 5, 8, 9, and 10, predose; Day 11, predose and 1, 2, 4, 8, and 24 hours postdose; Days 15 to 17, predose; Day 18, predose and 1, 2, 4, 8, and 24 hours postdose

• Part B: Plasma concentration of BOS-475

  Days 1, 2, 8, 21, 28, and 35: predose. Day 14: predose; 1 (±15 minutes [min]), 2 (±15 min), 4 (±30 min), and 8 (±2 hours [hr]) hr postdose. Day 15: predose (24 hr [±2 hr] postdose from previous dose on Day 14); at time of study visits on Days 43 and 56

Study Arms (4)

Part A: BOS-475

EXPERIMENTAL

Daily application of BOS-475 0.5%, 1%, or 2%

Drug: BOS-475

Part A: Vehicle cream

PLACEBO COMPARATOR

Daily application of vehicle cream

Drug: Vehicle

Part B: BOS-475

EXPERIMENTAL

Daily application of BOS-475 0.5%, 1%, or 2%

Drug: BOS-475

Part B: Vehicle cream

PLACEBO COMPARATOR

Daily application of vehicle cream

Drug: Vehicle

Interventions

BOS-475 DRUG

topical cream

Part A: BOS-475; Part B: BOS-475

Vehicle DRUG

topical cream

Part A: Vehicle cream; Part B: Vehicle cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A
• Healthy male or female participants 18 to 65 years of age inclusive, at the time of signing the informed consent.
• Male participants must agree to use contraception as detailed in the protocol during the treatment period and for at least 90 days (a spermatogenesis cycle) after the last dose of study drug and refrain from donating sperm during this period.
• o Male participants who have had a vasectomy with documentation of azoospermia are not required to use contraception.
• Female participants must be of non-child bearing potential, defined as 1) at least 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) \> 40 milliInternational Units per milliliter (mIU/ml), or 2) having a documented tubal ligation at least 6 weeks prior to dosing; or 3) having had a surgical bilateral oophorectomy (with or without hysterectomy).
• Participants who are healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Participants with body mass index (BMI) within the range 18 to 30 kilograms per meters squared (kg/m\^2) (inclusive).
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol
• Willing to refrain from using any topical treatments, other than those mandated by the protocol or for protocol procedures
• Part B
• Male or female participants with mild to moderate psoriasis 18 to 65 years of age inclusive, at the time of signing the informed consent
• Male participant must agree to use contraception as detailed in the protocol during the treatment period and for at least 90 days (a spermatogenesis cycle) after the last dose of study drug and refrain from donating sperm during this period.
• o Male participants who have had a vasectomy with documentation of azoospermia are not required to use contraception.
• Female of non-child bearing potential is defined as 1) at least 12 months of spontaneous amenorrhea with FSH \> 40 mIU/mL, or 2) having a documented tubal ligation at least 6 weeks prior to dosing; or 3) having had a surgical bilateral oophorectomy (with or without hysterectomy).
• Participants who have a clinical diagnosis of stable plaque psoriasis for ≥ 6 months, as confirmed by the Investigator

You may not qualify if:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or skin disorders, in the Investigator's opinion, may significantly alter the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data
• Current evidence of any acute cutaneous infection, history of repeated or chronic significant skin infections (unless irrelevant in the opinion of the Investigator, i.e., onychomycosis, labial herpes or other minor diagnosis)
• Women of child-bearing potential, is pregnant, or is breastfeeding
• Known history of chronic hepatitis or human immunodeficiency virus (HIV); positive findings of hepatitis B surface antigen or hepatitis C virus (HCV) antibody associated with a positive HCV ribonucleic acid (RNA) polymerase chain reaction; or positive HIV screening test suggesting active disease at the screening visit
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• Abnormal blood pressure, liver, or renal function
• History of malignancy within 5 years prior to dosing, except adequately treated non-invasive skin cancer (basal or squamous cell carcinoma)
• History of hypersensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study
• For Part A only: psoriasis of any kind (i.e., plaque, acute psoriasis guttate, psoriasis punctata, psoriasis erythroderma, or pustular psoriasis)
• For Part A only: any clinically-relevant skin disease or other skin pathologies, that may, in the opinion of the Investigator, contraindicate participation or interfere with skin evaluations
• For Part A only: history or risk of complications from skin biopsy including impaired wound healing, excess bleeding, infection, or scarring/keloid formation or known hypersensitivity to local anesthetics. Use of anticoagulant medication.
• Use of prohibited concomitant medications or natural products within the defined periods before the Day 1 visit and during the trial
• Current heavy smoker (those who smoke ≥ 25 cigarettes a day) or former heavy smoker who has stopped smoking within 1 month prior to screening
• Positive urine drug or alcohol test results during screening, or at Day 1, or history of drug abuse within a year prior to the screening visit
• Excess alcohol consumption within 6 months prior to the study defined as an average weekly intake of \> 14 units for males and females. One unit is equivalent to 8 grams of alcohol: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits

Sponsors & Collaborators

• Boston Pharmaceuticals: lead

Study Sites (3)

CMAX Clinical Research

Adelaide, Australia

Location

Sinclair Dermatology

East Melbourne, Australia

Location

Linear

Nedlands, Australia

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaobing Qian, MD, PhD

  Boston Pharmaceuticals, Vice President, Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: April 23, 2019
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)