Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 529 · 1 trial · 1 indication
Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal. A serious adverse event was defined as an adverse event that met at least 1 of the following criteria: * fatal * life threatening * required in patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
| Arm | Type | Description |
|---|---|---|
| AMG 529 | EXPERIMENTAL | Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection. |
| Placebo | PLACEBO_COMPARATOR | Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection. |
| Name | Type | Description |
|---|---|---|
| AMG 529 | DRUG | Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection |
| Placebo | DRUG | Single doses of matching placebo by SC or IV injection |
Inclusion Criteria: 1. Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders 2. Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening 3. Women must be of non-reproductive potential as defined in protocol 4. Other inclusion...
AMG 529 is an investigational small molecule being developed by Amgen Inc. for cardiovascular conditions. It is currently in Phase 1 clinical development, meaning it has not been approved by the FDA and is still being studied for safety and tolerability in humans.
AMG 529 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its potential effects in cardiovascular disease, though the exact mechanism of action is not publicly available at this time.
AMG 529 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for cardiovascular indications.
AMG 529 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by the FDA. The drug is being studied in early-stage trials to assess its safety, tolerability, and pharmacokinetics in healthy volunteers.
AMG 529 has one completed Phase 1 clinical trial, identified as NCT03170193, titled 'AMG 529 First in Human Study.' This trial enrolled 48 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
No alternative names for AMG 529 have been disclosed. It is identified solely by its development code, AMG 529, and is being studied by Amgen for cardiovascular conditions.