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Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

NCT06388642 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.

Conditions

Interventions

DRUG

Afamelanotide 16mg implant

afamelanotide 16mg implant will be administered to each patient during the study.

Sponsors & Collaborators

  • Clinuvel Europe Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-10-28
Completion
2025-01-20
FDA Drug
Yes

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388642 on ClinicalTrials.gov