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NCT03570346

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects

Status unknown Phase 1 Last updated 2 October 2018
What this trial tests

Phase 1 trial testing Hemay005 in Psoriasis in 24 participants. Status unknown.

Timeline
10 July 2018
Primary endpoint
20 October 2018
1 December 2018

Quick facts

Lead sponsorTianjin Hemay Bio-Tech Co., Ltd
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment24
Start date10 July 2018
Primary completion20 October 2018
Estimated completion1 December 2018
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Hemay Bio-Tech Co., Ltd

Who can join

Adults 18 to 60, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. A total of approximately 24 subjects will be randomized into 3 cohorts(15mg, 30mg, 60mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort. This study includes an 28-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period, and an End of Study Visit occurring approximately 11days (±3 days) after study drug administration.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. An Overview of PDE4 Inhibitors in Clinical Trials: 2010 to Early 2022.
    Crocetti L, Floresta G, Cilibrizzi A, Giovannoni MP. · · 2022 · cited 85× · PMID 35956914 · DOI 10.3390/molecules27154964

Verify or expand the search:

Other trials of Hemay005

Trials testing the same drug.

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

Other Tianjin Hemay Bio-Tech Co., Ltd trials

Trials by the same sponsor.

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