Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841

Summary

The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study. The study will evaluate 5 dose levels of the investigational product, in 5 cohorts of 8 healthy volunteers per cohort. In each cohort, 6 volunteers will receive the investigational product and 2 volunteers will receive placebo.

Timeline

Start

2024-06

Primary completion

2025-06

Completion

2026-06

Outcome

Outcome not reported

Stopped: “FDA reviewers asked for Phase 1 study in Oncology subjects, not in healthy volunteers.”

Drugs

Indications

No indication recorded.