NCT04815551

A Phase 1 Study of AV-380 in Healthy Subjects

A Phase 1, First-in-human, Randomized, Placebo Controlled, Double Blind, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AV-380 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

Conditions

• Cachexia

Interventions

Type	Name	Description
DRUG	AV-380	AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
DRUG	Placebo	Placebo is sterile liquid for IV infusion.

Timeline

• Start date: 2021-02-22
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2021-03-25
• Last updated: 2023-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study