Evidence map›Paper›PMID 42181873›Full record

Trial reportFrontiers in pharmacology2026

A randomized controlled phase Ia clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of tofacitinib tartrate cream (HZ-J001) in healthy Chinese subjects.

Kunhong Deng, Jie Huang, Qian Wu, Jinlian Xie, Xiaoyan Yang, Shuang Yang, Li Liu, Yafang Gong, Wanyao Shen, Ling Cai and 2 more

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kunhong Deng *Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Jie Huang *Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Qian WuCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Jinlian XieCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Xiaoyan YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Shuang YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Li LiuCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Yafang GongGynecology Department, The Third Xiangya Hospital, Central South University, Changsha, China.
Wanyao ShenHubei Chengtian Pharmaceutical Co., Ltd., Tianmen, China.
Ling CaiHubei Chengtian Pharmaceutical Co., Ltd., Tianmen, China.
Guoping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Chengxian GuoCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: HZ-J001 is a novel topical tofacitinib tartrate cream designed to optimize local pharmacokinetics (PKs) and minimize systemic adverse events (AEs). This study aimed to evaluate the safety, tolerability, and PK characteristics of HZ-J001 cream in healthy Chinese subjects. Methods: This randomized, double-blind, placebo-controlled Phase Ia trial included both single-ascending-dose (SAD) and multiple-dose (MD) phases. Healthy subjects were enrolled into 5 sequential cohorts (10 HZ-J001 and 2 placebo per cohort). SAD Cohorts 1-3 received single doses of HZ-J001 cream at strengths of 1.0%, 1.5%, and 2.0%, respectively, each applied to a fixed area of 20% body surface area (BSA) (3,200 cm Results: A total of 61 subjects were enrolled and 60 received study drug. HZ-J001 cream was well-tolerated and no serious TEAEs or discontinuations occurred. The most common TEAEs by system organ class were investigations. Local tolerability was acceptable, with only mild application-site reactions reported. Systemic exposure following single-dose administration was low (C Conclusion: HZ-J001 cream demonstrated a favorable safety profile and a PK characteristic of minimal systemic exposure in healthy subjects, supporting its further development as a topical therapy for atopic dermatitis.

Indexed as

JAK inhibitorpharmacokineticsphase I trialsafetytofacitinib

Identifiers

PMID42181873
PMCPMC13190169

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.