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

Hangzhou Yirui Pharmaceutical Technology

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis; Psoriasis

Treatments: Drug: YR001 Dose A on middle body surface area; Drug: YR001 Dose B on low body surface area; Drug: YR001 Dose B on high body surface area twice daily; Drug: Placebo on high body surface area twice daily; Drug: YR001 Dose B on middle body surface area; Drug: YR001 Dose A on high body surface area twice daily; Drug: YR001 Dose A on low body surface area; Drug: YR001 Dose A on high body surface area; Drug: Placebo on middle body surface area; Drug: Placebo on high body surface area; Drug: Placebo on low body surface area; Drug: YR001 Dose B on high body surface area

Study type: Interventional

Funder types: Industry

Identifiers

NCT05718921

YR001-A01

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

12. Drug or alcohol abuse history.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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54 participants in 12 patient groups, including a placebo group

Part A, Active dose A and Low body surface area

Experimental group

Description:

The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration

Treatment:

Drug: YR001 Dose A on low body surface area

Part A, Active dose A and Middle body surface area

Experimental group

Description:

The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration

Treatment:

Drug: YR001 Dose A on middle body surface area

Part A, Active dose A and High body surface area

Experimental group

Description:

The intervention is YR001 Dose A on high body surface area, low dose for single topical administration

Treatment:

Drug: YR001 Dose A on high body surface area

Part A, Active dose B and Low body surface area

Experimental group

Description:

The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration

Treatment:

Drug: YR001 Dose B on low body surface area

Part A, Active dose B and Middle body surface area

Experimental group

Description:

The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration

Treatment:

Drug: YR001 Dose B on middle body surface area

Part A, Active dose B and High body surface area

Experimental group

Description:

The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration

Treatment:

Drug: YR001 Dose B on high body surface area

Part A, Placebo and Low body surface area

Placebo Comparator group

Description:

The intervention is Placebo on low body surface area, Placebo for single topical administration

Treatment:

Drug: Placebo on low body surface area

Part A, Placebo and Middle body surface area

Placebo Comparator group

Description:

The intervention is Placebo on middle body surface area, Placebo for single topical administration

Treatment:

Drug: Placebo on middle body surface area

Part A, Placebo and High body surface area

Placebo Comparator group

Description:

The intervention is Placebo on high body surface area, Placebo for single topical administration

Treatment:

Drug: Placebo on high body surface area

Part B, Active dose A and High body surface area

Experimental group

Description:

The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration

Treatment:

Drug: YR001 Dose A on high body surface area twice daily

Part B, Active dose B and High body surface area

Experimental group

Description:

The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration

Treatment:

Drug: YR001 Dose B on high body surface area twice daily

Part B, Placebo and High body surface area

Placebo Comparator group

Description:

The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration

Treatment:

Drug: Placebo on high body surface area twice daily