Phase 1
Completed N=48
AMG 529 First in Human Study
Cardiovascular
Source: ClinicalTrials.gov NCT03170193 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 3; 0; 0; 2 Participants
Summary
A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
3; 0; 0; 2; 2; 3 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of AMG 529 |
6.90; 23.8; 2010; 9370; 35600; 3460 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of AMG 529 |
24; 5.8; 72; 72; 96; 0.5 | — |
| SECONDARY Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529 |
5.99; 46.0; 5370; 41800; 289000; 766 | — |
| SECONDARY Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time |
62.0; 69.0; 56.0; 68.0; 57.7; 57.5 | — |
| SECONDARY Change From Baseline in Total Cholesterol Concentration Over Time |
4.5817; 5.3567; 4.8383; 5.3417; 4.2483; 4.8533 | — |
| SECONDARY Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time |
2.8317; 3.2683; 2.8400; 3.4017; 2.4633; 3.2267 | — |
| SECONDARY Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time |
1.1775; 1.3783; 1.3950; 1.4133; 1.2633; 1.0700 | — |
| SECONDARY Change From Baseline in Triglycerides Concentration Over Time |
1.2292; 1.1100; 1.0050; 1.3750; 1.0533; 1.5067 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders
- Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening
- Women must be of non-reproductive potential as defined in protocol
- Other inclusion criteria may apply
Exclusion Criteria
- Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product
- Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product
- Men with partners who are pregnant or planning to become pregnant while the subject is on study through 90 days after receiving the dose of investigational product
- Positive pregnancy test at screening or day -1
- Other exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03170193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.