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NCT03570346
Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects
Phase 1 trial testing Hemay005 in Psoriasis in 24 participants. Status unknown.
20 October 2018
Quick facts
| Lead sponsor | Tianjin Hemay Bio-Tech Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 10 July 2018 |
| Primary completion | 20 October 2018 |
| Estimated completion | 1 December 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- Hemay005 — full drug profile →
- Placebo
Conditions studied
- Psoriasis — all drugs for Psoriasis →
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):
-
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:
- PubMed search for NCT03570346
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hemay005
Trials testing the same drug.
- NCT06610890 — Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets · Phase 1 · completed
- NCT06610903 — Bioequivalence Test of Hemay005 Tablets · Phase 1 · completed
- NCT06380153 — To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment · Phase 1 · completed
- NCT06376474 — To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage · Phase 1 · recruiting
- NCT06145893 — A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease · Phase 3 · recruiting
Other recruiting trials for Psoriasis
Currently open trials in the same condition.
- NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
- NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
- NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
- NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
- NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting
Other Tianjin Hemay Bio-Tech Co., Ltd trials
Trials by the same sponsor.
- NCT03577626 — A Food Effect Study to Assess Pharmacokinetics of Hemay005 in Healthy Volunteers · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03570346 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tianjin Hemay Bio-Tech Co., Ltd
- Last refreshed: 2 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03570346.
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