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NCT05549219 · ClinicalTrials.gov registry record · Phase 2
24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Participants With PMM2-CDG
A Phase 2 study, sponsored by Glycomine.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT05549219 is a Phase 2 study that has completed, run by Glycomine. The registered enrollment target is 27 participants.
The verdict
NCT05549219, a Phase 2 study, has completed, sponsored by Glycomine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, open-label, 24-week treatment study to evaluate the potential pharmacodynamic (PD) activity, safety, tolerability, and pharmacokinetics (PK) of GLM101 in adult, adolescent, and pediatric, patients with a confirmed diagnosis of PMM2-CDG. The planned doses of GLM101 to be investigated are 10, 20, and 30 mg/kg. The study will consist of a Screening Period, a 24-week (6-month) Treatment Period, and a 30-day (1-month) Follow-Up Period.
Interventions
- DRUG GLM101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2025-11-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05549219
The ClinicalTrials.gov registry entry for NCT05549219 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glycomine, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GLM101 is the first listed.
NCT05549219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05549219 about?
NCT05549219 is a clinical study titled "24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Participants With PMM2-CDG". This is a Phase 2, randomized, open-label, 24-week treatment study to evaluate the potential pharmacodynamic (PD) activity, safety, tolerability, and pharmacokinetics (PK) of GLM101 in adult, adolescent, and pediatric, patients with a confirmed diagnosis of PMM2-CDG. The planned doses of GLM101 to b...
What is the current status of trial NCT05549219?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2022-11-29. Estimated completion is 2025-11-18.
What interventions are being tested in trial NCT05549219?
The interventions under investigation include: GLM101 (DRUG).
Who is sponsoring clinical trial NCT05549219?
This trial is sponsored by Glycomine, which has 3 total clinical trials registered on ClinicalTrials.gov.
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