NCT05773586

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.

A Phase 1, Ascending Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of APG-5918 in Healthy Volunteers and Patients With Anemia.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.

Detailed description

The trial is composed of ttwo parts. Part A is a randomized, double-blind, placebo- controlled, single-dose escalation study in up to 7 cohorts to evaluate the safety, tolerability, and PK characteristics of APG-5918 in healthy volunteers and to explore whether MTDS will be achieved within the range of projected therapeutic doses for anemia. Part B is an open-label,, multi-dose escalation trial in up to 6 cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of APG-5918 in patients with anemia.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	APG-5918	oral tablets 10mg, 50mg, 200mg.
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2023-03-13
• Primary completion: 2027-12-31
• Completion: 2028-07-15
• First posted: 2023-03-17
• Last updated: 2026-04-15

Locations

2 sites across 1 country: China