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

Sponsor
Pulmongene Ltd.
Study ID
NCT07615985
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • PMG1016 Dose 1 — DRUG
    Participants will be administered PMG1016 Dose 1 or placebo in a 100 mL IV infusion volume
  • PMG1016 Dose 2 — DRUG
    Participants will be administered PMG1016 Dose 2 or placebo in a 100 mL IV infusion volume
  • PMG1016 Dose 3 — DRUG
    Participants will be administered PMG1016 dose 3 or placebo in a 100 mL IV infusion volume
  • PMG1016 Dose 4 — DRUG
    Participants will be administered PMG1016 dose 4 or placebo in a 100 mL IV infusion volume

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
May 22, 2026
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2
  • Experimental: Cohort 3
  • Experimental: Cohort 4

Primary Outcome Measure

Treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 57 ]

Central Contacts

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