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A Study to Test the Safety and Blood Levels of PMG1016 in Healthy Adults

NCT07615985 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-29

No results posted yet for this study

Summary

This study is a first-in-human (FIH), randomized, double-blind, placebo-controlled study of PMG1016 in healthy adult participants. It aims to investigate the safety, tolerability, PK, and immunogenicity of PMG1016 administered via IV infusion.

Cohort 1: Healthy participants receiving single doses of PMG1016 Dose 1 or placebo.

Cohort 2: Healthy participants receiving single doses of PMG1016 Dose 2 or placebo.

Cohort 3: Healthy participants receiving single doses of PMG1016 Dose 3 or placebo.

Cohort 4: Healthy participants receiving single doses of PMG1016 Dose 4 or placebo.

Conditions

Interventions

DRUG

PMG1016 Dose 1

Participants will be administered PMG1016 Dose 1 or placebo in a 100 mL IV infusion volume

DRUG

PMG1016 Dose 2

Participants will be administered PMG1016 Dose 2 or placebo in a 100 mL IV infusion volume

DRUG

PMG1016 Dose 3

Participants will be administered PMG1016 dose 3 or placebo in a 100 mL IV infusion volume

DRUG

PMG1016 Dose 4

Participants will be administered PMG1016 dose 4 or placebo in a 100 mL IV infusion volume

Sponsors & Collaborators

  • Pulmongene Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-05-22
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Australia

Study Locations

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Entities

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 NCT07615985 on ClinicalTrials.gov