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Also known as GLPG3121 SAD, GLPG3121 MAD
GLPG3121 · 2 trials · 1 indication
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo.
| Arm | Type | Description |
|---|---|---|
| GLPG3121 SAD | EXPERIMENTAL | Single doses of GLPG3121 at up to 3 dose levels in ascending order |
| Placebo SAD | PLACEBO_COMPARATOR | Single doses of placebo |
| GLPG3121 MAD | EXPERIMENTAL | Multiple doses of GLPG3121 at up to 3 dose levels in ascending order |
| Placebo MAD | PLACEBO_COMPARATOR | Multiple doses of placebo |
| GLPG3121 FE fed | EXPERIMENTAL | Single dose of GLPG3121 in fed state |
| GLPG3121 FE fasted | EXPERIMENTAL | Single dose of GLPG3121 in fasted state |
| Name | Type | Description |
|---|---|---|
| GLPG3121 | DRUG | GLPG3121 modified-release tablet |
| Placebo | DRUG | Matching placebo |
| GLPG3121 SAD | DRUG | GLPG3121 oral suspension, single ascending doses |
| Placebo SAD | DRUG | Placebo oral suspension |
| GLPG3121 MAD | DRUG | GLPG3121 oral suspension, multiple ascending doses, daily for 13 days |
| Placebo MAD | DRUG | Placebo oral suspension, daily for 13 days |
Inclusion Criteria: * Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). * A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, phy...
GLPG3121 is an investigational small molecule drug developed by Lakefront Biotherapeutics. It has been studied in Phase 1 clinical trials in healthy adult male volunteers. The specific disease indications being pursued have not been disclosed. Two Phase 1 trials of GLPG3121 have been completed, enrolling a total of 81 participants.
GLPG3121 targets TYK2, a kinase enzyme. TYK2 is a member of the Janus kinase family and plays a role in immune signaling pathways. By targeting this kinase, GLPG3121 is designed to modulate TYK2-mediated signaling. It is a small molecule therapeutic candidate.
GLPG3121 is being developed by Lakefront Biotherapeutics, which trades under the ticker symbol LKFT. The company is the sponsor of the clinical trials evaluating GLPG3121 in healthy volunteers. No partnership or licensing details for this asset have been disclosed.
GLPG3121 is in Phase 1 clinical development. Both of its Phase 1 trials have been completed, and no active trials are currently listed. It is an investigational drug and has not been approved by the FDA for any indication. Further clinical development would be required before any potential approval.
GLPG3121 has been evaluated in two completed Phase 1 trials. NCT04856358 tested single and multiple doses of a modified-release formulation in 50 healthy adult male subjects in Germany. NCT03899909 evaluated single and multiple oral doses in 31 healthy adult male subjects in Belgium. Both were randomized, double-blind, and placebo-controlled.
Yes, GLPG3121 SAD and GLPG3121 MAD refer to the same investigational drug, GLPG3121. SAD stands for single ascending dose and MAD for multiple ascending dose, which describe the dosing designs used in its Phase 1 trials. These are trial design labels, not separate drug candidates.