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A Phase 2, Randomized, Open-Label, 12-Week Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult Participants with PMM2-CDG

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Clinical Trial

2022-000565-40 Recruiting, Active
A Phase 2, Randomized, Open-Label, 12-Week Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult Participants with PMM2-CDG

A Phase 2, Randomized, Open-Label, 12-Week Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult Participants with PMM2-CDG

Phase 2
Interventional

Disease

Disease type

Other

Orphan drug recognition

Yes

Patient type

Adult

Children

Inclusion / Exclusion

Opening date

04/11/2022

Inclusion criteria :

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Exclusion criteria :

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Funding

private

Members involved

Others investigators

Dr Marta Morales Ballús

Representative

Spain

Anterior Segment Rare Eye Diseases (WG4), CPMS & Digital Medecine (TWG10), Genetic Diagnostics (TWG6), National Integration (TWG9), Pediatric Ophthalmology Rare Diseases (WG3), Registries & Epidemiology (TWG7), Research (TWG8)
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ERN EYE member investigating site

HCP : Principal investigators