A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers

Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Single and Multiple Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Topical Ointment YR001 in Adult Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05718921
• Other study ID #: YR001-A01
• Status: Completed
• Phase: Phase 1
• Start date: April 8, 2023
• Est. completion date: December 14, 2023

Study information

• Verified date: January 2024
• Source: Hangzhou Yirui Pharmaceutical Technology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Written informed consent obtained from the subject

2. Male or female subject is aged between 18 and 65 years

3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2

4. Free from any clinically relevant illness or disease incl. skin disorder that may adversely affect the safety of the subject or the integrity of the study

Exclusion Criteria:

1. Presence or history of a clinically significant medical condition or other condition that might interfere with the safety, tolerability and PK assessment of ointment YR001, or place the subject at an unacceptable risk as a subject in this study.

2. Pregnant or lactating women.

3. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.

4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.

5. Have active infectious disease.

6. Subjects treated with another investigational drug, biological agent, or device

7. Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.

8. Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.

9. Active untreated mental or psychiatric disorder.

10. Any major surgery within 6 months of screening.

11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.

13. Drug or alcohol abuse history.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Psoriasis

Intervention

Drug:
• YR001 Dose A on low body surface area
Part A: Single topical dose
• YR001 Dose A on middle body surface area
Part A: Single topical dose
• YR001 Dose A on high body surface area
Part A: Single topical dose
• YR001 Dose B on low body surface area
Part A: Single topical dose
• YR001 Dose B on middle body surface area
Part A: Single topical dose
• YR001 Dose B on high body surface area
Part A: Single topical dose
• Placebo on low body surface area
Part A: Single topical dose
• Placebo on middle body surface area
Part A: Single topical dose
• Placebo on high body surface area
Part A: Single topical dose
• YR001 Dose A on high body surface area twice daily
Part B: Multiple topical dose
• YR001 Dose B on high body surface area twice daily
Part B: Multiple topical dose
• Placebo on high body surface area twice daily
Part B: Multiple topical dose

Locations

Country	Name	City	State
United States	California Dermatology & Clinical Research Institute	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Safety and Maximum Tolerate Dose (MTD)	Incidence of treatment related AEs (TRAEs) and local skin tolerance	day 0 to day 8
Primary	Part B: Safety and Maximum Tolerate Dose (MTD)	Incidence of treatment related AEs (TRAEs) and local skin tolerance	day 0 to day 22
Secondary	Part A: all treatment-emergent AEs	Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)	day 0 to day 8
Secondary	Part B: all treatment-emergent AEs	Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)	day 0 to day 22