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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.
Participants will be enrolled and randomized into 1 of 4 cohorts in a double-blind manner
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMG1016 Dose 1 | Drug | Participants will be administered PMG1016 Dose 1 or placebo in a 100 mL IV infusion volume |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-drug antibodies (ADA) | Percentage of PMG1016-induced ADA positive participants and percentage of PMG1016-boosted ADA positive participants | From Day 1 to Day 57 |
| Maximum serum PMG1016 concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaohui Wang | Contact | +86 13810669548 | yaohui_wang@pulmongene.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network (Brisbane) | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| PMG1016 Dose 2 | Drug | Participants will be administered PMG1016 Dose 2 or placebo in a 100 mL IV infusion volume |
|
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| PMG1016 Dose 3 | Drug | Participants will be administered PMG1016 dose 3 or placebo in a 100 mL IV infusion volume |
|
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| PMG1016 Dose 4 | Drug | Participants will be administered PMG1016 dose 4 or placebo in a 100 mL IV infusion volume |
|
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| 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 |
Determine PMG1016 Cmax in Serum
| Varying timepoints through end of treatment, up to Day 57 |
| Time to maximum concentration (Tmax) | Determine PMG1016 Tmax in Serum. | 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. | Varying timepoints through end of treatment, up to Day 57 |
| AUC from time zero to infinity (AUC0-∞) | Determine PMG1016 AUC0-∞ in Serum. | 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. | Varying timepoints through end of treatment, up to Day 57 |
| Terminal elimination half-life (t1/2) | Determine PMG1016 t1/2 in Serum. | Varying timepoints through end of treatment, up to Day 57 |
| Apparent total body clearance (CL) | Determine PMG1016 CL in Serum. | Varying timepoints through end of treatment, up to Day 57 |
| Apparent volume of distribution during the terminal phase (Vz) | Determine PMG1016 Vz in Serum. | Varying timepoints through end of treatment, up to Day 57 |
| Apparent terminal elimination rate constant (λz) | Determine PMG1016 λz in Serum. | Varying timepoints through end of treatment, up to Day 57 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |