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NCT05514353
A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream
Phase 1 trial testing PBI-100 Topical Cream in Healthy Volunteers in 32 participants. Completed in 12 January 2023.
12 January 2023
Quick facts
| Lead sponsor | Pyramid Biosciences |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 28 December 2021 |
| Primary completion | 12 January 2023 |
| Estimated completion | 12 January 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PBI-100 Topical Cream — full drug profile →
- Vehicle Cream — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Psoriasis — all drugs for Psoriasis →
Sponsor
Pyramid Biosciences — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy Volunteers or Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1, randomized, double-blind, vehicle-controlled, SAD / MAD study evaluating three dose levels of PBI-100 topical cream in healthy adult volunteers and/or subjects with psoriasis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05514353
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PBI-100 Topical Cream
Trials testing the same drug.
- NCT04882631 — A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants · Phase 1 · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
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Other Pyramid Biosciences trials
Trials by the same sponsor.
- NCT05692570 — A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers · Phase 1 · completed
- NCT05690932 — A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers · Phase 1 · completed
- NCT05238337 — A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 · Phase 1 · completed
- NCT05160389 — A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 · Phase 1 · completed
- NCT04901806 — Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors · Phase 1 · terminated
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 NCT05514353 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pyramid Biosciences
- Last refreshed: 29 March 2023
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/NCT05514353.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing