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A Phase 2, Randomized, Open-Label, 24-Week Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult, Adolescent and Pediatric Participants with PMM2-CDG

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513119-29-00
Acronym
GLM101-002
Enrollment
19
Registered
2024-04-22
Start date
2022-12-02
Completion date
2025-10-02
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PMM2-CDG

Brief summary

Change in ICARS

Detailed description

Evaluation of safety through the collection of safety parameters: AEs, AESIs (including Infusion-Associated Reactions), SAEs, deaths, and discontinuations due to AEs, clinical laboratory tests (hematology, chemistry, and urinalysis), ECG, vital signs, and PE findings, Concentrations of total M1P to estimate PK parameters including Cmax, Clast, tmax, tlast, t1/2, AUC0-last, AUC0-∞, AUC0-tau, %AUCex, CL, Vz, Vss, and λz

Interventions

DRUGGLM101

Sponsors

Glycomine Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change in ICARS—

Secondary

MeasureTime frame
Evaluation of safety through the collection of safety parameters: AEs, AESIs (including Infusion-Associated Reactions), SAEs, deaths, and discontinuations due to AEs, clinical laboratory tests (hematology, chemistry, and urinalysis), ECG, vital signs, and PE findings, Concentrations of total M1P to estimate PK parameters including Cmax, Clast, tmax, tlast, t1/2, AUC0-last, AUC0-∞, AUC0-tau, %AUCex, CL, Vz, Vss, and λz—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026