New kidney drug PMG1016 enters first human safety trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.