NCT04941313

Phase 1 Study of 3D229 in Healthy Subjects

A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and Tolerability of 3D-229 by Intravenous Single Dose Escalation and Repeated Doses in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: 3D Medicines · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects

Detailed description

A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 by Intravenous Single Dose Escalation(SAD) and Repeated Doses(RD) in Healthy Subjects. A SAD portion of the study consists of 2 sequential dose escalation cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses of 3D229. In both SAD and RD study arms, subjects are randomized to receive either a study intervention (3D229) or matching placebo.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	3D229	3D229 is an investigational drug.
OTHER	Placebo	Matching placebo

Timeline

• Start date: 2021-07-27
• Primary completion: 2021-11-15
• Completion: 2022-02-21
• First posted: 2021-06-28
• Last updated: 2022-06-22

Locations

1 site across 1 country: China