Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis

NCT04544943 | Completed Phase 1 DMC

• 1 other identifier: AD-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of BioLexa™ and active control (gentamicin only)

  Measured by Incidence of Treatment-Emergent Adverse Events

  Measurements at Baseline till Follow-up/EOS visit (14 days) or early termination

Secondary Outcomes (5)

• 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 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

• 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 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)

Study Arms (3)

Cohort 1

EXPERIMENTAL

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.

Drug: BioLexa- Cohort 1; Drug: Placebo; Drug: Gentamicin

Cohort 2

PLACEBO COMPARATOR

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.

Drug: BioLexa- Cohort 2; Drug: Placebo; Drug: Gentamicin

Open-Label

EXPERIMENTAL

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

Drug: BioLexa- Cohort 1

Interventions

BioLexa- Cohort 1 DRUG

Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects

Cohort 1; Open-Label

BioLexa- Cohort 2 DRUG

Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients

Cohort 2

Placebo DRUG

Twice daily (BID) application of placebo for 14 days

Cohort 1; Cohort 2

Gentamicin DRUG

Twice daily (BID) application of Gentamicin for 14 days

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• 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).
• Male and Female, 18 to 65 years (Cohort 2 - adult patients)
• Physician documented history or confirmed diagnosis of mild to moderate AD for at least 6 months prior to screening. AD should be diagnosed by EASI score of Mild or Moderate on Day 1;
• Mild to moderate AD with a minimum of 3% to a maximum of 27% BSA involvement on Day 1 (excluding the scalp, designated venous access areas, palms and soles);
• Participant has a minimum of 2 AD lesions;
• Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the patient, as required by local laws;

You may not qualify if:

• 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)
• Abnormal ECG findings at Screening that are considered by the Investigator to be clinically significant; (Part A and B)
• History or presence of a condition associated with significant immunosuppression; (Part A and B)
• History of life-threatening infection (e.g. meningitis); (Part A and B)
• Infections requiring parenteral antibiotics within the 6 months prior to Screening; (Part A and B)
• Have used antiseptic treatments (e.g. bleach baths, potassium permanganate etc.) within 1 month before Baseline visit. (Patients who have recently used antiseptic treatment may be rescreened at a later date if they wish to participate in the study and agree to stop antiseptic treatment)

Sponsors & Collaborators

• Hoth Therapeutics, Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Novatrials

Kotara, New South Wales, 2289, Australia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Oscar Cumming, Dr

  Novatrials

  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: August 27, 2020
• First Posted: September 10, 2020
• Study Start: May 17, 2021
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)