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.
Age range
18 Years – 55 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Treatment-emergent adverse events (TEAEs)
Timeframe: Day 1 to Day 57
Serious adverse events (SAEs)
Timeframe: From Day 1 to Day 57
Number of participants with abnormal pulse rate
Timeframe: From Day 1 to Day 57
Number of participants with abnormal blood pressure
Timeframe: From Day 1 to Day 57
Number of participants with abnormal respiratory rate
Timeframe: From Day 1 to Day 57
Number of participants with abnormal tympanic temperature
Timeframe: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal PR Interval
Timeframe: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QRS Duration
Timeframe: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QT interval
Timeframe: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal RR interval
Timeframe: From Day 1 to Day 57
Number of Participants with Clinically Significant Valvular Abnormalities
Timeframe: Day 1 to Day 29
Number of Participants with Clinically Significant Abnormal Left Ventricular Ejection Fraction
Timeframe: Day 1 to Day 29
Number of Participants with Clinically Significant Abnormal Hematology Results
Timeframe: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Clinical Chemistry Results
Timeframe: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Urinalysis Results
Timeframe: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Physical Examination Findings
Timeframe: Day 1 to Day 57