NCT06219499

Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841 When Administered Intravenously in Healthy Adult Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OncoC4, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ONC-841	ONC-841 is a humanized monoclonal antibody.
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2024-01-23
• Last updated: 2024-04-03

Regulatory

• FDA-regulated drug study