Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06181370 | Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF | PHASE1 | RECRUITING | 145 | — | — | Dec 1, 2023 | Jun 1, 2026 | Dec 31, 2025 | 1 | United Kingdom |
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...