NCT07108894

A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AbCellera Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo

Detailed description

This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 5 planned cohorts (A1 to A5), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A5.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	ABCL575	Participants will receive SC injection of ABCL575
BIOLOGICAL	Placebo (Normal Saline 0.9%)	Participants will receive SC injection of placebo (Normal Saline 0.9%)

Timeline

• Start date: 2025-07-25
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-08-07
• Last updated: 2026-03-23

Locations

1 site across 1 country: Canada