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

NCT07615985 | Not Yet Recruiting Phase 1

• 1 other identifier: PMG1016-1031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (16)

• Treatment-emergent adverse events (TEAEs)

  The incidence and severity occurred

  Day 1 to Day 57

• Serious adverse events (SAEs)

  The incidence and severity occurred

  From Day 1 to Day 57

• Number of participants with abnormal pulse rate

  From Day 1 to Day 57

• Number of participants with abnormal blood pressure

  From Day 1 to Day 57

• Number of participants with abnormal respiratory rate

  From Day 1 to Day 57

• Number of participants with abnormal tympanic temperature

  From Day 1 to Day 57

• Number of Participants with Clinically Significant Abnormal PR Interval

  From Day 1 to Day 57

• Number of Participants with Clinically Significant Abnormal QRS Duration

  From Day 1 to Day 57

• Number of Participants with Clinically Significant Abnormal QT interval

  From Day 1 to Day 57

• Number of Participants with Clinically Significant Abnormal RR interval

  From Day 1 to Day 57

• Number of Participants with Clinically Significant Valvular Abnormalities

  The number of participants with clinically significant valvular abnormalities identified by transthoracic echocardiography (TTE)

  Day 1 to Day 29

• Number of Participants with Clinically Significant Abnormal Left Ventricular Ejection Fraction

  The number of participants with clinically significant abnormalities in left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography (TTE)

  Day 1 to Day 29

• Number of Participants with Clinically Significant Abnormal Hematology Results

  Day 1 to Day 57

• Number of Participants with Clinically Significant Abnormal Clinical Chemistry Results

  Day 1 to Day 57

• Number of Participants with Clinically Significant Abnormal Urinalysis Results

  Day 1 to Day 57

• Number of Participants with Clinically Significant Abnormal Physical Examination Findings

  assessment of general appearance; head; ears; eyes; nose; throat; dentition; thyroid; chest (heart and lungs); abdomen; skin; neurological system; extremities; back; neck; musculoskeletal system; and lymph nodes

  Day 1 to Day 57

Secondary Outcomes (10)

• Incidence of anti-drug antibodies (ADA)

  From Day 1 to Day 57

• Maximum serum PMG1016 concentration (Cmax)

  Varying timepoints through end of treatment, up to Day 57

• Time to maximum concentration (Tmax)

  Varying timepoints through end of treatment, up to Day 57

• Area under the serum drug concentration-time curve (AUC) from time zero to the last time point with measurable concentration (AUC0-t)

  Varying timepoints through end of treatment, up to Day 57

• AUC from time zero to infinity (AUC0-∞)

  Varying timepoints through end of treatment, up to Day 57

Study Arms (4)

Cohort 1

EXPERIMENTAL

Drug: PMG1016 Dose 1

Cohort 2

EXPERIMENTAL

Drug: PMG1016 Dose 2

Cohort 3

EXPERIMENTAL

Drug: PMG1016 Dose 3

Cohort 4

EXPERIMENTAL

Drug: PMG1016 Dose 4

Interventions

PMG1016 Dose 2 DRUG

Participants will be administered PMG1016 Dose 2 or placebo in a 100 mL IV infusion volume

Also known as: PMG1016

Cohort 2

PMG1016 Dose 3 DRUG

Participants will be administered PMG1016 dose 3 or placebo in a 100 mL IV infusion volume

Also known as: PMG1016

Cohort 3

PMG1016 Dose 4 DRUG

Participants will be administered PMG1016 dose 4 or placebo in a 100 mL IV infusion volume

Also known as: PMG1016

Cohort 4

PMG1016 Dose 1 DRUG

Participants will be administered PMG1016 Dose 1 or placebo in a 100 mL IV infusion volume

Also known as: PMG1016

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulmongene Ltd.: lead

Study Sites (1)

Nucleus Network (Brisbane)

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yaohui Wang

CONTACT

+86 13810669548; yaohui_wang@pulmongene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 29, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)