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NCT00656825COMPLETEDanonymous

Multicentre, Placebo-Controlled, Multi-Dosis, Phase I Clinical Trial to Evaluate the Tolerability and Bioavailability of TGF β1 Inhibitor Peptide 144 After Topical Administration in Healthy Volunteers.

Sponsor

Source record

ISDIN

Phase

Source record

Phase 1

Modality

AI-normalized

small molecule

Target

AI-normalized

Transforming Growth Factor-beta 1 (TGF-β1) type III receptor (betaglycan)

Indication / condition

AI-normalized

Healthy

Intervention

Source record

P144 cream, P144 cream, P144 cream, Placebo

Source & freshness

Source record

NCT ID

NCT00656825

Original source

ClinicalTrials.gov

Source last updated

Nov 05, 2008

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT00656825

Title

Multicentre, Placebo-Controlled, Multi-Dosis, Phase I Clinical Trial to Evaluate the Tolerability and Bioavailability of TGF β1 Inhibitor Peptide 144 After Topical Administration in Healthy Volunteers.

Sponsor

ISDIN

Status

COMPLETED

Phase

Phase 1

Condition raw

Healthy

Condition normalized

Healthy

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Transforming Growth Factor-beta 1 (TGF-β1) type III receptor (betaglycan)

Target normalized

Transforming Growth Factor-beta 1 (TGF-β1) type III receptor (betaglycan)

Interventions

P144 cream, P144 cream, P144 cream, Placebo

Public preview

Source record

The P144 peptide inhibitor, developed by ISDIN, targets TGF-β1, a key mediator in fibrotic diseases, particularly systemic sclerosis. Given the lack of approved treatments for skin fibrosis associated with systemic sclerosis in both the EU and the US, P144 presents a significant market opportunity. The trial's focus on topical administration suggests a potential for a novel therapeutic approach in dermatology. The competitive landscape includes existing antifibrotic therapies, but P144's mechanism of action may provide a differentiated profile. Diligence should focus on the safety and tolerability data from the trial, as well as the regulatory pathway for approval.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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