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This is a single-center, open-label, fixed-sequence, Phase 1 study in healthy adult participants to evaluate the effect of AGMB-129 on the PK of a single dose of MDZ in healthy participants.
A total of 14 participants will be enrolled and will receive study intervention in a fixed-sequence scheme. All IP will be administered orally and in fed conditions.
The total duration of involvement for each participant, screening through follow-up, will be approximately 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AGMB-129 and MDZ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGMB-129 | Drug | Oral capsule |
| |
| MDZ |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for MDZ | Day 1 to Day 13 | |
| Cmax for 1-OH-midazolam | Day 1 to Day 13 | |
| AUC0-∞ for MDZ | Day 1 to Day 13 | |
| AUC0-∞ for 1-OH-midazolam | Day 1 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for AGMB-129 | Day 3 to Day 14 | |
| Cmax for MET-154 | Day 3 to Day 14 | |
| Cmax for MET-158 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Wiesel, MD | Agomab Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium | Edegem | Belgium |
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| Drug |
Pre-filled oral syringes |
|
| Day 3 to Day 14 |
| AUC0-t for AGMB-129 | Day 3 to Day 14 |
| AUC0-t for MET-154 | Day 3 to Day 14 |
| AUC0-t for MET-158 | Day 3 to Day 14 |
| AUC0-24 for AGMB-129 | Day 3 to Day 14 |
| AUC0-24 for MET-154 | Day 3 to Day 14 |
| AUC0-24 for MET-158 | Day 3 to Day 14 |
| Number of participants with adverse events | To evaluate the safety and tolerability of AGMB-129 in terms of adverse events at every visit | From Screening to Day 15 |
| Number of participants with abnormal clinical laboratory values | To evaluate the safety and tolerability of AGMB-129 in terms of abnormal laboratory parameters at every visit | From Screening to Day 15 |
| Number of participants with abnormal vital signs | To evaluate the safety and tolerability of AGMB-129 in terms of vital signs at every visit | From Screening to Day 15 |
| Number of participants with abnormal physical exams | To evaluate the safety and tolerability of AGMB-129 in terms of physical exams at every visit | From Screening to Day 15 |