๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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/mยฒ 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 ร 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 (โฅ500 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 \>37.5ยฐC 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.