Chronic Kidney DiseasePhase 1NCT07615985
Phase 1a Study Assessing Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016
A Phase 1 study testing PMG1016 Dose 1, PMG1016 Dose 2 and PMG1016 Dose 3 in people with Chronic Kidney Disease, run by Pulmongene Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- PMG1016 Dose 1, PMG1016 Dose 2 and PMG1016 Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 29 May 2026to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network (Brisbane)
Brisbane, Queensland, 4006
Richard Friend, Dr, (07) 3707 2720, r.friend@nucleusnetwork.com.au
About this study
Official title: A Phase 1a, First-in-human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016 in Healthy Volunteers
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.
Read the detailed description
Participants will be enrolled and randomized into 1 of 4 cohorts in a double-blind manner
- Conditions
- Chronic Kidney Disease
- Being tested
- PMG1016 Dose 1, PMG1016 Dose 2, PMG1016 Dose 3, PMG1016 Dose 4
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMG1016 Dose 1Drug
Also called PMG1016
Participants will be administered PMG1016 Dose 1 or Placebo in a 100mL IV infusion Volume
PMG1016 Dose 2Drug
Also called PMG1016
Participants will be administered PMG1016 Dose 2 or Placebo in a 100mL IV infusion Volume
PMG1016 Dose 3Drug
Also called PMG1016
Participants will be administered PMG1016 Dose 3 or Placebo in a 100mL IV infusion Volume
PMG1016 Dose 4Drug
Also called PMG1016
Participants will be administered PMG1016 Dose 4 or Placebo in a 100mL IV infusion Volume
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: PMG1016 Dose 1 |
| Cohort 2 | Experimental | Not described Receives: Drug: PMG1016 Dose 2 |
| Cohort 3 | Experimental | Not described Receives: Drug: PMG1016 Dose 3 |
| Cohort 4 | Experimental | Not described Receives: Drug: PMG1016 Dose 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
The incidence and severity occurred
Measured: Day 1 to Day 57
Serious adverse events (SAEs)
The incidence and severity occurred
Measured: From Day 1 to Day 57
Number of participants with abnormal pulse rate
Measured: From Day 1 to Day 57
Number of participants with abnormal blood pressure
Measured: From Day 1 to Day 57
Number of participants with abnormal respiratory rate
Measured: From Day 1 to Day 57
Number of participants with abnormal tympanic temperature
Measured: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal PR Interval
Measured: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QRS Duration
Measured: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QT interval
Measured: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal RR interval
Measured: 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)
Measured: 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)
Measured: Day 1 to Day 29
Number of Participants with Clinically Significant Abnormal Hematology Results
Measured: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Clinical Chemistry Results
Measured: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Urinalysis Results
Measured: 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
Measured: Day 1 to Day 57
Secondary outcomes (10)
Incidence of anti-drug antibodies (ADA)
Percentage of PMG1016-induced ADA positive participants and percentage of PMG1016-boosted ADA positive participants
Measured: From Day 1 to Day 57
Maximum serum PMG1016 concentration (Cmax)
Determine PMG1016 Cmax in Serum
Measured: Varying timepoints through end of treatment, up to Day 57
Time to maximum concentration (Tmax)
Determine PMG1016 Tmax in Serum.
Measured: 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)
Determine PMG1016 AUC and AUC0-t in Serum.
Measured: Varying timepoints through end of treatment, up to Day 57
AUC from time zero to infinity (AUC0-∞)
Determine PMG1016 AUC0-∞ in Serum.
Measured: Varying timepoints through end of treatment, up to Day 57
The extrapolated portion of AUC0-∞ from Tlast to infinity (%AUCextrap)
Determine PMG1016 %AUCextrap in Serum.
Measured: Varying timepoints through end of treatment, up to Day 57
Terminal elimination half-life (t1/2)
Determine PMG1016 t1/2 in Serum.
Measured: Varying timepoints through end of treatment, up to Day 57
Apparent total body clearance (CL)
Determine PMG1016 CL in Serum.
Measured: Varying timepoints through end of treatment, up to Day 57
Apparent volume of distribution during the terminal phase (Vz)
Determine PMG1016 Vz in Serum.
Measured: Varying timepoints through end of treatment, up to Day 57
Apparent terminal elimination rate constant (λz)
Determine PMG1016 λz in Serum.
Measured: Varying timepoints through end of treatment, up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start29 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmongene Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615985
- Sponsor's protocol ID
- PMG1016-1031
- Status last verified
- Sep 2026
- First submitted
- 10 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, First-in-human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07615985
- Acronym / sponsor ID
- PMG1016-1031
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pulmongene Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be enrolled and randomized into 1 of 4 cohorts in a double-blind manner
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMG1016 Dose 1Also: PMG1016Participants will be administered PMG1016 Dose 1 or Placebo in a 100mL IV infusion Volume | Drug | Cohort 1 |
| PMG1016 Dose 2Also: PMG1016Participants will be administered PMG1016 Dose 2 or Placebo in a 100mL IV infusion Volume | Drug | Cohort 2 |
| PMG1016 Dose 3Also: PMG1016Participants will be administered PMG1016 Dose 3 or Placebo in a 100mL IV infusion Volume | Drug | Cohort 3 |
| PMG1016 Dose 4Also: PMG1016Participants will be administered PMG1016 Dose 4 or Placebo in a 100mL IV infusion Volume | Drug | Cohort 4 |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to Day 57
The incidence and severity occurred
Serious adverse events (SAEs)
Time frame: From Day 1 to Day 57
The incidence and severity occurred
Number of participants with abnormal pulse rate
Time frame: From Day 1 to Day 57
Number of participants with abnormal blood pressure
Time frame: From Day 1 to Day 57
Number of participants with abnormal respiratory rate
Time frame: From Day 1 to Day 57
Number of participants with abnormal tympanic temperature
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal PR Interval
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QRS Duration
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QT interval
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal RR interval
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Valvular Abnormalities
Time frame: Day 1 to Day 29
The number of participants with clinically significant valvular abnormalities identified by transthoracic echocardiography (TTE)
Number of Participants with Clinically Significant Abnormal Left Ventricular Ejection Fraction
Time frame: Day 1 to Day 29
The number of participants with clinically significant abnormalities in left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography (TTE)
Number of Participants with Clinically Significant Abnormal Hematology Results
Time frame: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Clinical Chemistry Results
Time frame: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Urinalysis Results
Time frame: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Physical Examination Findings
Time frame: Day 1 to Day 57
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
10 secondary outcomes
Incidence of anti-drug antibodies (ADA)
Time frame: From Day 1 to Day 57
Maximum serum PMG1016 concentration (Cmax)
Time frame: Varying timepoints through end of treatment, up to Day 57
Time to maximum concentration (Tmax)
Time frame: 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)
Time frame: Varying timepoints through end of treatment, up to Day 57
AUC from time zero to infinity (AUC0-∞)
Time frame: Varying timepoints through end of treatment, up to Day 57
The extrapolated portion of AUC0-∞ from Tlast to infinity (%AUCextrap)
Time frame: Varying timepoints through end of treatment, up to Day 57
Terminal elimination half-life (t1/2)
Time frame: Varying timepoints through end of treatment, up to Day 57
Apparent total body clearance (CL)
Time frame: Varying timepoints through end of treatment, up to Day 57
Apparent volume of distribution during the terminal phase (Vz)
Time frame: Varying timepoints through end of treatment, up to Day 57
Apparent terminal elimination rate constant (λz)
Time frame: Varying timepoints through end of treatment, up to Day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PMG1016 Dose 1, PMG1016 Dose 2 and PMG1016 Dose 3 in people with Chronic Kidney Disease, run by Pulmongene Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaohui Wang (+86 13810669548, yaohui_wang@pulmongene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: Day 1 to Day 57). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.