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Also known as SAD IV Dose 1 - 150mg ABS201 IV Single Dose
SAD Dose 1- ABS201 Single Dose · 1 trial · 2 indications
Safety assessments based on reporting of Treatment Emergent Adverse Events, together with clinically significant changes in vital signs, 12-lead ECG parameters, physical examination findings and clinical safety laboratory tests, and change in neurobehavioral symptoms (PHQ-9 and GAD-7).
| 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 |
|---|---|---|
| SAD IV Dose 1 - 150mg ABS201 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...