Health TrialsbyHealthPanel

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

ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPulmongene Ltd.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • PMG1016 Dose 1

    Drug

    Participants will be administered PMG1016 Dose 1 or Placebo in a 100mL IV infusion Volume

  • PMG1016 Dose 2

    Drug

    Participants will be administered PMG1016 Dose 2 or Placebo in a 100mL IV infusion Volume

  • PMG1016 Dose 3

    Drug

    Participants will be administered PMG1016 Dose 3 or Placebo in a 100mL IV infusion Volume

  • PMG1016 Dose 4

    Drug

    Participants will be administered PMG1016 Dose 4 or Placebo in a 100mL IV infusion Volume

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment-emergent adverse events (TEAEs)

The incidence and severity occurred

Time frame
Day 1 to Day 57
2

Serious adverse events (SAEs)

The incidence and severity occurred

Time frame
From Day 1 to Day 57
3

Number of participants with abnormal pulse rate

Time frame
From Day 1 to Day 57
4

Number of participants with abnormal blood pressure

Time frame
From Day 1 to Day 57

Secondary outcomes

1

Incidence of anti-drug antibodies (ADA)

Percentage of PMG1016-induced ADA positive participants and percentage of PMG1016-boosted ADA positive participants

Time frame
From Day 1 to Day 57
2

Maximum serum PMG1016 concentration (Cmax)

Determine PMG1016 Cmax in Serum

Time frame
Varying timepoints through end of treatment, up to Day 57
3

Time to maximum concentration (Tmax)

Determine PMG1016 Tmax in Serum.

Time frame
Varying timepoints through end of treatment, up to Day 57
4

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.

Time frame
Varying timepoints through end of treatment, up to Day 57

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pulmongene Ltd.

Lead sponsor

Source ClinicalTrials.gov
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