A Randomised, Double-Blind, Vehicle Controlled, Sequential Group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Overview
- Phase
- Phase 1
- Intervention
- BioLexa- Cohort 1
- Conditions
- Atopic Dermatitis
- Sponsor
- Hoth Therapeutics, Inc.
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of BioLexa™ and active control (gentamicin only)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a Phase 1, randomised, double-blind, vehicle controlled study to determine the safety, tolerability, PK and efficacy of twice daily application of topical BioLexa™ lotion, administered for 28 days in adult healthy subjects, in adult patients with mild to moderate AD and in adolescent patients with mild to moderate AD.
Detailed Description
This study will consist of 3 parts. Part A: Part A will consist of Cohort 1 constituting of heathy subjects. The total body surface area (BSA) dosed will be either 9% or 27% BSA for Cohort 1 subjects. Part A will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control, applied at 9% or 27% BSA. Part B: Part B will consist of Cohort 2 made up of adult mild to moderate AD patients. The minimum %BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients in Cohort 2. Part B will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control. Open-Label Cohort: After closure of Part B, open-label enrolment of patients with mild to moderate atopic dermatitis affecting 3-27% BSA for treatment with BioLexa for 14 days (unblinded).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female volunteers, aged 18 to 65 years
- •Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug; (Part A)
- •Participants must have a BMI between ≥ 18.0 and ≤ 35.0 kg/m2 at Screening; (Part A and B)
- •Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate; (Part A and B)
- •Participants must be a non-smoker or a smoker who smokes no more than 2 cigarettes or equivalent per week in order to be included in the study; (Part A and B)
- •Participants must have no relevant dietary restrictions, and be willing to consume standard meals provided; (Part A and B)
- •Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from screening until study completion, including the follow-up period.
- •Males must not donate sperm for at least 90 days after the last dose of study drug (Part A and B);
- •Participants must have the ability and willingness to attend the necessary visits to the CRU (Part A and B);
- •Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures (Part A and B).
Exclusion Criteria
- •Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; (Part A and B)
- •Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant; (Part A and B)
- •Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol; (Part A and B)
- •Blood donation or significant blood loss within 60 days prior to the first study drug administration; (Part A and B)
- •Plasma donation within 7 days prior to the first study drug administration; (Part A and B)
- •Fever (body temperature \>38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening; (Part A and B)
- •History of severe allergic or anaphylactic reactions; (Part A and B)
- •Known contact sensitivity to aminoglycosides; (Part A and B)
- •Contact sensitivity to BioLexa or any formulation ingredients; (Part A and B)
- •History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening; (Part A and B)
Arms & Interventions
Cohort 1
Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The total body surface area (BSA) dosed will be either 9% or 27% BSA. Part A will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control, applied at 9% or 27% BSA.
Intervention: BioLexa- Cohort 1
Cohort 1
Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The total body surface area (BSA) dosed will be either 9% or 27% BSA. Part A will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control, applied at 9% or 27% BSA.
Intervention: Placebo
Cohort 1
Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The total body surface area (BSA) dosed will be either 9% or 27% BSA. Part A will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control, applied at 9% or 27% BSA.
Intervention: Gentamicin
Cohort 2
Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The minimum % BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients in Cohort 2. Part B will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control.
Intervention: BioLexa- Cohort 2
Cohort 2
Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The minimum % BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients in Cohort 2. Part B will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control.
Intervention: Placebo
Cohort 2
Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The minimum % BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients in Cohort 2. Part B will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control.
Intervention: Gentamicin
Open-Label
Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The minimum % BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients
Intervention: BioLexa- Cohort 1
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of BioLexa™ and active control (gentamicin only)
Time Frame: Measurements at Baseline till Follow-up/EOS visit (14 days) or early termination
Measured by Incidence of Treatment-Emergent Adverse Events
Secondary Outcomes
- To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- AUC(Measurements at Baseline till the end of the study (14 days))
- To evaluate the preliminary efficacy of BioLexa™ and active control (gentamicin only) in patients with mild to moderate AD (Part B only)- by Eczema Area and Severity Index (EASI) score(Measured on Day 7, 14, 21 and 28)
- To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Cmax(Measurements at Baseline till the end of the study (14 days))
- To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Tmax(Measurements at Baseline till the end of the study (14 days))
- To evaluate the preliminary efficacy of BioLexa™ in patients with mild to moderate AD (Part B only)- by Scoring Atopic Dermatitis(Measured on on Day 7, 14, 21 and 28)