NCT05022771

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015

A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Pulmongene Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody, being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after Single ascending doses (SAD).

Detailed description

Participants will be enrolled and randomized into 1 of 7 cohorts in a double-blind manner.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	PMG1015 Dose 1	Dose level 1 of PMG1015
DRUG	PMG1015 Dose 2	Dose level 2 of PMG1015
DRUG	PMG1015 Dose 3	Dose level 3 of PMG1015
DRUG	PMG1015 Dose 4	Dose level 4 of PMG1015
DRUG	PMG1015 Dose 5	Dose level 5 of PMG1015
DRUG	PMG1015 Dose 6	Dose level 6 of PMG1015
DRUG	Placebo	Placebo to match
DRUG	PMG1015 Dose 7	Dose level 7 of PMG1015

Timeline

• Start date: 2021-10-14
• Primary completion: 2022-08-18
• Completion: 2022-08-18
• First posted: 2021-08-26
• Last updated: 2023-01-31

Locations

1 site across 1 country: Australia