Phase 1a Study Assessing Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016
Sponsor: Pulmongene Ltd. • ClinicalTrials.gov ID: NCT07615985
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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.
Interventions
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PMG1016 Dose 1
(Drug)
Participants will be administered PMG1016 Dose 1 or Placebo in a 100mL IV infusion Volume
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PMG1016 Dose 2
(Drug)
Participants will be administered PMG1016 Dose 2 or Placebo in a 100mL IV infusion Volume
-
PMG1016 Dose 3
(Drug)
Participants will be administered PMG1016 Dose 3 or Placebo in a 100mL IV infusion Volume
-
PMG1016 Dose 4
(Drug)
Participants will be administered PMG1016 Dose 4 or Placebo in a 100mL IV infusion Volume
Eligibility criteria
Conditions
Locations
- Nucleus Network (Brisbane) — Brisbane, Queensland, Australia
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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