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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07317544 | Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia | PHASE1 | RECRUITING | 227 | — | — | Dec 3, 2025 | Jul 1, 2028 | May 22, 2026 | 4 | Australia |
Safety assessments based on reporting of Treatment Emergent Adverse Events
| Arm | Type | Description |
|---|---|---|
| SAD IV Dose 1 - 150mg ABS201 or Placebo | EXPERIMENTAL | ABS-201 IV Single Dose |
| SAD IV Dose 2 - 450mg ABS201 or Placebo | EXPERIMENTAL | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| SAD IV Dose 3 - 900mg ABS201 or Placebo | EXPERIMENTAL | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| SAD IV Dose 4 - 1800mg ABS201 or Placebo | EXPERIMENTAL | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| MAD SC Dose 1 - 300mg ABS201 or Placebo | EXPERIMENTAL | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| MAD SC Dose 2 - 600mg ABS201 or Placebo | EXPERIMENTAL | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| MAD SC Dose 2 - 1200mg ABS201 or Placebo | EXPERIMENTAL | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| Name | Type | Description |
|---|---|---|
| ABS-201 IV Single Dose | DRUG | ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR), |
| Placebo IV | DRUG | Matching placebo |
| ABS-201 SC Multiple Doses | DRUG | Multiple doses of ABS-201 for Subcutaneous injection |
| Placebo SC Injection | DRUG | Subcutaneous Placebo injection for MAD arms |
Inclusion Criteria (Major): * Participants must be overtly healthy, as determined by medical evaluation, which includes a review of medical and surgical history, physical examination, and a 12-lead ECG. * Must have normal ranges for hematology, clinical chemistry, coagulation tests, and urine analy...