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Phase 1/2a for Safety, PK and PD of SQY51 in Paediatric and Adult Patients Duchenne Muscular Dystrophy

NCT05753462 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-04-01

No results posted yet for this study

Summary

This is a Phase 1/2a, monocentric, open label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of SQY51 in patients with Duchenne muscular dystrophy

Conditions

Interventions

DRUG

Phase 1, SQY51

SQY51 is administered by intravenous infusion.

DRUG

Phase 2a, SQY51 (cohort 1)

SQY51 is administered by intravenous infusion at dose 1

DRUG

Phase 2a, SQY51 (cohort 2)

SQY51 is administered by intravenous infusion at dose 2.

DRUG

Phase 2a, SQY51 (cohort 3)

SQY51 is administered by intravenous infusion at dose 3.

Sponsors & Collaborators

  • Biotrial

    collaborator INDUSTRY

  • Sqy Therapeutics

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • France

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 NCT05753462 on ClinicalTrials.gov