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

NCT05022771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-01-31

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Pulmongene Ltd.

    lead INDUSTRY

Principal Investigators

  • Richard Friend · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2022-08-18
Completion
2022-08-18

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022771 on ClinicalTrials.gov