HZ-J001: Phase Ia Clinical Trial Data for Tofacitinib Cream in Healthy Chinese Subjects

61 subjects were enrolled in a randomized, double-blind, placebo-controlled Phase Ia trial evaluating the safety and pharmacokinetics of HZ-J001 cream. The study included single-ascending-dose and multiple-dose phases across five cohorts, with drug applied to 20-30% of body surface area. Author Kunhong Deng published the results under a CC-BY-4.0 license on figshare, last updated on 2026-05-07.

Use Cases

• Analyze safety and tolerability profiles based on treatment-emergent adverse event data mentioned in the description
• Model pharmacokinetic characteristics based on reported systemic exposure metrics like Cmax and AUC
• Compare dose-response relationships based on the single-ascending-dose cohorts testing 1.0%, 1.5%, and 2.0% strengths
• Assess local application site reactions based on the reported mild application-site reactions

Strengths

• Data originates from a structured Phase Ia clinical trial with a randomized, double-blind, placebo-controlled design
• Includes results from 61 enrolled subjects across five sequential cohorts with specific dosing regimens
• Reports specific pharmacokinetic parameters such as Cmax (0.09–0.16 ng/mL) and AUC (7.24–12.18 h·ng/mL)

Limitations

• The dataset is a 120.3 KB DOCX file, which is a small supplementary document rather than a primary data table
• Row count and column-level documentation are absent; field semantics must be inferred after download
• Data is specific to a single Phase Ia trial in healthy Chinese subjects, which may limit generalizability

Provenance

Source

figshare

Collection Method

Data was collected during a randomized controlled Phase Ia clinical trial.

Freshness

Last updated 2026-05-07 05:30:52; freshness should be verified

Geography

Study was conducted on healthy Chinese subjects.