Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGMB-447 · 1 trial · 1 indication
To evaluate the safety and tolerability of AGMB-447 in terms of AE at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal laboratory parameters at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of abnormal ECGs at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of vital signs at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of physical exams at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of spirometry at every visit
| Arm | Type | Description |
|---|---|---|
| AGMB-447 | EXPERIMENTAL | Participants will receive a single dose of AGMB-447 (part A), multiple doses of AGMB-447 over 7 days (part B) or multiple doses of AGMB-447 over 14 days (part C) |
| placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo (part A), multiple doses of placebo over 7 days (part B) or multiple doses of placebo over 14 days (part C) |
| Name | Type | Description |
|---|---|---|
| AGMB-447 | DRUG | AGMB-447 inhaled drug |
| placebo | OTHER | placebo inhaled drug |
Inclusion criteria for Healthy Participants (Parts A and B): * Male and female participants aged between 18-55 years inclusive, at the time of informed consent. * Participants must have FEV1 ≥80% predicted at screening and prior to randomization on Day -1 or Day 1 of treatment period 1 (using Globa...
AGMB-447 is an investigational small molecule being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive lung disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AGMB-447 is being developed by AgomAb Therapeutics NV, a biopharmaceutical company. The company's stock ticker is AGMB.
AGMB-447 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study has been completed to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics.
AGMB-447 has one completed Phase 1 clinical trial, identified as NCT06181370. This study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGMB-447 in healthy participants and participants with IPF. The trial enrolled 143 participants and was conducted in the United Kingdom.
AGMB-447 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial was designed to evaluate safety and tolerability, and further studies would be needed to support any regulatory approval.