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This is a single-center, open-label, single-dose, randomized, 3-period cross-over, Phase 1 study in healthy adult participants to assess the BA of AGMB-129 tablet formulation relative to that of the reference capsule formulation and to assess the effect of food on the BA of a single oral dose of the AGMB-129 tablet formulation.
A total of 24 participants will be enrolled. Participants will be randomized to 1 of 6 intervention sequences (Williams design) according to a 6-sequence, 3-period design. In 3 sequential intervention periods, each participant will receive 3 study interventions, 1 in each intervention period. 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 | ABC with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
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| 2 | Experimental | CAB with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
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| 3 | Experimental | BCA with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
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| 4 | Experimental | CBA with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
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| 5 | Experimental | BAC with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
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| 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGMB-129 | Drug | Each participant will receive 3 study interventions, 1 in each intervention period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for AGMB-129 | From baseline to Day 3 | |
| Cmax for MET-158 | From baseline to Day 3 | |
| Cmax for MET-154 | From baseline to Day 3 | |
| AUC0-t for AGMB-129 | From baseline to Day 3 | |
| AUC0-t for MET-158 | From baseline to Day 3 | |
| AUC0-t for MET-154 | From baseline to Day 3 | |
| AUC0-∞ for AGMB-447 | From baseline to Day 3 | |
| AUC0-∞ for MET-158 | From baseline to Day 3 | |
| AUC0-∞ for MET-154 | From baseline to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 5 |
| Number of participants with abnormal clinical laboratory values |
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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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ACB with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
|
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal laboratory parameters at every visit
| From Screening to Day 5 |
| 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 5 |
| 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 5 |