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RECRUITING
NCT07615985
PHASE1

Phase 1a Study Assessing Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016

Sponsor: Pulmongene Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1a, First-in-human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016 in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-05-29

Completion Date

2026-11-30

Last Updated

2026-09-23

Healthy Volunteers

Yes

Interventions

DRUG

PMG1016 Dose 1

Participants will be administered PMG1016 Dose 1 or Placebo in a 100mL IV infusion Volume

DRUG

PMG1016 Dose 2

Participants will be administered PMG1016 Dose 2 or Placebo in a 100mL IV infusion Volume

DRUG

PMG1016 Dose 3

Participants will be administered PMG1016 Dose 3 or Placebo in a 100mL IV infusion Volume

DRUG

PMG1016 Dose 4

Participants will be administered PMG1016 Dose 4 or Placebo in a 100mL IV infusion Volume

Locations (1)

Nucleus Network (Brisbane)

Brisbane, Queensland, Australia