NCT05344989

A First-in-Human Study to Assess Single Doses of APNmAb005 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APNmAb005 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: APRINOIA Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. the starting dose of APNmAb005 is 5 mg/kg and the anticipated doses for subsequent cohorts are 10, 25, 50 and 70 mg/kg. A Safety Review Team (SRT) will review data on an ongoing basis throughout the study and before progression to the next dose level cohort. Subjects will receive a single dose of either APNmAb005 or placebo administered as a single IV infusion on Day 1 of the study and will remain in the study center until Day 3 (48 hours after dosing). They will return to the study center for 7 outpatient visits. The duration of the study, excluding screening, is approximately 71 days.

Conditions

• Healthy Volunteers
• Tauopathies
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	APNmAb005	Administered by IV infusion
DRUG	Placebo	Administered by IV infusion

Timeline

• Start date: 2022-05-06
• Primary completion: 2024-03-01
• Completion: 2024-07-01
• First posted: 2022-04-25
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study