NCT05116969

A Phase 1 Study of PTX-35 in Healthy Volunteers

A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Heat Biologics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers

Detailed description

This is a double blind, placebo controlled, Phase 1 study of PTX-35 administered via IV infusion to healthy male and female participants. This study will be conducted in 2 stages: * Stage 1 is a single ascending dose (SAD) escalation period in which 5 dose levels of PTX-35 will be evaluated. * Stage 2 is a multiple dose period in which the highest tolerated dose determined from Stage 1 will be tested in 2 different treatment regimens in 2 cohorts (i.e., 7- and 14- days dosing regimen).

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	PTX-35	PTX-35 is a humanized, affinity matured, IgG2 monoclonal antibody

Timeline

• Start date: 2021-11-24
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2021-11-11
• Last updated: 2022-02-17

Regulatory

• FDA-regulated drug study