NCT07615985 Phase 1a Study Assessing Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 30 participants in total. It began in 2026-05-29 with a primary completion date of 2026-11-30.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Participants must be in good health based on medical history, physical exam, vital signs, ECG, and lab results at screening, as judged by the PI. * BMI 17.5-32.0 kg/m² and body weight 50-100 kg for males or 45-100 kg for females * No clinically significant lab abnormalities (hematology, coagulation, biochemistry, urinalysis) per PI discretion * Females: Must be non-pregnant, non-lactating, and use double contraception (condom + hormonal method/vaginal ring/IUD) through study completion, unless surgically sterile, postmenopausal, or in same-sex relationships. Negative pregnancy tests required. No oocyte donation for 90 days post dose. * Males: Must be surgically sterile, abstinent, or use condoms plus a highly effective method for female partners. Vasectomized males without proof of azoospermia must use condoms with WOCBP partners. No sperm donation for 90 days post dose. Exclusion Criteria: * History or evidence of any clinically significant medical condition (e.g., cardiovascular, gastrointestinal, endocrine, hematologic, psychiatric, renal, musculoskeletal, infectious, neurological, or other major disease) as determined by the PI. * A PR \<40 or \>100 bpm or mean SBP \>140 mmHg or DBP \>95 mmHg (based on triplicate supine measurements after 5 minutes' rest). * Mean QTcF \>450 ms (males) or \>470 ms (females) at Screening; one repeat triplicate ECG allowed at PI discretion * Any clinically significant ECG abnormalities (rhythm, conduction, morphology) that may affect QTc interpretation, per PI judgment * ALT, AST, or creatinine \>1.5 × ULN, or total bilirubin or lymphocytes \> ULN. * Hemoglobin (HGB) below the lower limit of the normal range (ULN) prior to enrollment. * Participants with a positive toxicology screening panel or positive alcohol breath test at Screening and on Day -1. * Regular alcohol consumption defined as \> 21 alcohol units per week. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and while residing at the CRU. * Blood donation or significant blood loss (≥500 mL) within 60 days prior to the first IP administration. * Plasma donation within 7 days prior to the first IP administration. * Use of any investigational product/device within 30 days or 5 half-lives (whichever is longer), or participation in \>4 investigational drug studies in the past year. * Pregnant or lactating at Screening or planning pregnancy (self or partner) during the study or follow-up. * Fever \>37.5°C or symptomatic infection within 2 weeks before Screening; any infection requiring systemic antibiotics within 3 months; history of recurrent infections; or a positive SARS-CoV-2 PCR before CRU admission. * Active malignancy, history of malignancy, or untreated precancerous lesions. Adequately treated or fully excised precancerous lesions are allowed. * Participants with a known history of retinal diseases, including conditions such as prior retinal detachment. * Participants with a history of recurrent epistaxis or gingival bleeding. * Use of prescription medications (except hormonal contraception) within 2 weeks before dosing; mAb products within 5 half-lives; or OTC drugs, supplements, or herbal products within 7 days before dosing. * History of anaphylaxis or severe allergy per PI judgment; mild untreated hay fever may be allowed. * History of allergic reaction or hypersensitivity to any of the excipients in the IP. * Positive screening test for HIV-1/2, HBsAg, HCV antibody, or syphilis. * Any condition that, in the PI's judgment, may pose a risk to the participant or the study.

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