Healthy Adult Participants
Conditions
Brief summary
A Phase I Study of ADB116 for Injection in Healthy Chinese Adults. This study aims as follows: Primary Objective: • To evaluate the safety and tolerability of a single intravenous bolus dose of ADB116 for injection in healthy Chinese adults. Secondary Objective: • To evaluate the pharmacokinetic (PK) profile of a single intravenous bolus dose of ADB116 for injection.
Detailed description
This trial is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose Phase I clinical trial conducted in healthy Chinese adults to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of a single intravenous bolus dose of ADB116 for injection in healthy Chinese adults. A total of 34 healthy adults will be enrolled across 6 dose cohorts. For Cohort 1, ADB116 0.03 mg/kg (starting dose) will be administered as a single intravenous injection. Following safety and tolerability assessment, if the dose escalation stopping criteria are not met, the dose will be escalated sequentially using a modified Fibonacci method to Cohorts 2-6: 0.06, 0.09, 0.12, 0.18, and 0.24 mg/kg. After each dose level has been observed through the end of Day 3 (D3), and upon assessment by the sponsor and investigator confirming no safety concerns, the next dose cohort may proceed. The study consists of three periods: a screening period (up to 28 days, D-28 to D-1), a treatment period (D1), and a follow-up period (D2 to D8). On the dosing day, a single intravenous bolus dose of ADB116 or placebo will be administered.
Interventions
DRUGADB116 for Injection
ADB116 for Injection, single intravenous bolus injection
DRUGPlacebo for ADB116 for Injection
Matching placebo, single intravenous bolus injection
Sponsors
Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily sign the informed consent form (ICF) prior to any study procedures and be able to comply with the protocol requirements. 2. Aged between 18 and 45 years (inclusive of 18 years up to but not including 46 years) at the time of signing the ICF, male or female. 3. At screening, male subjects must weigh ≥50.0 kg, female subjects must weigh ≥45.0 kg, and body mass index (BMI) = weight (kg) / height² (m²) must be within the range of 19.0-26.0 kg/m² (inclusive). 4. No history of major medical or surgical diseases prior to screening, and results of vital signs, physical examination, 12-lead ECG, laboratory tests, fundoscopic examination, chest X-ray, and abdominal ultrasound during the screening period must be normal or, if slightly outside the normal reference range, considered clinically insignificant by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Safety and tolerability assessed by the frequency, relationship to treatment, severity (using CTCAE criteria, if applicable), seriousness, and expectedness of TEAEs, including adverse drug reactions (ADRs), Grade ≥3 AEs, serious adverse events (SAEs), serious adverse drug reactions (SADRs), AEs leading to treatment interruption, and AEs leading to premature study withdrawal. |
| Pharmacokinetic (PK) parameters：Cmax | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Cmax is defined as the highest concentration of the drug reached in the body (usually in plasma, whole blood, or serum) after administration. |
| Pharmacokinetic (PK) parameters： AUC0-t | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Area under the plasma concentration-time curve from time zero to the last measurable concentration |
| Pharmacokinetic (PK) parameters： AUC0-∞ | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Area under the plasma concentration-time curve from time zero extrapolated to infinity |
| Pharmacokinetic (PK) parameters：t1/2 | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | The time required for the concentration of a drug in the body (typically in plasma) to decrease by one-half. |
| Pharmacokinetic (PK) parameters：Vz/F | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | The theoretical volume in which the total amount would need to be uniformly distributed to produce the observed plasma concentration |
| Pharmacokinetic (PK) parameters：CL/F | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability (F). It reflects the efficiency of drug elimination following extravascular administration. |
| Pharmacokinetic (PK) parameters：λz | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Terminal elimination rate constant |
| Pharmacokinetic (PK) parameters：percentage of AUC extrapolated (AUC_%Extrap) | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Percentage of AUCinf due to extrapolation from Tlast to infinity |
| Pharmacokinetic (PK) parameters： MRT0-t | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Mean residence time from time zero to the last measurable concentration |
| Pharmacokinetic (PK) parameters： MRT0-∞ | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Mean residence time from time zero extrapolated to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coagulation function parameters：thrombin time (TT) | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes from baseline in thrombin time (TT) |
| Coagulation function parameters：activated partial thromboplastin time (APTT) | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes from baseline in activated partial thromboplastin time (APTT) |
| Coagulation function parameters：prothrombin time (PT) | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes from baseline in prothrombin time (PT) |
| Coagulation function parameters：fibrinogen (FIB) | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes from baseline in fibrinogen (FIB) |
| Coagulation function parameters：fibrin/fibrinogen degradation products (FDP) | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes from baseline in fibrin/fibrinogen degradation products (FDP) |
| Coagulation function parameters：plasma D-dimer | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes from baseline in plasma D-dimer |
| Injection site reactions | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Incidence and severity of local injection site reactions, assessed by the presence of pain, tenderness, erythema (redness), and induration (nodules/swelling) at the injection site. |
| Electrocardiogram (ECG): heart rate | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Heart rate in beat per minute |
| Electrocardiogram (ECG): PR interval | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes in PR interval |
| Electrocardiogram (ECG): QRS duration | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes in QRS duration |
| Electrocardiogram (ECG): QTc interval | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes in QTc interval |
| Vital sign: Sitting blood pressure (systolic and diastolic) | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Systolic and diastolic blood pressure in millimeters (mm) of mercury (Hg)Time |
| Vital sign: pulse | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Pulse in beat per minute |
| Vital sign: temperature | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Temperature in degree Celsius |
| Physical examination:skin | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in skin examination, categorized as medical history, AE, or other. |
| Physical examination: general appearance | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in general appearance examination, categorized as medical history, AE, or other. |
| Physical examination:head | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in head examination, categorized as medical history, AE, or other. |
| Physical examination:eyes | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in eyes examination, categorized as medical history, AE, or other |
| Physical examination: ears | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in ears examination, categorized as medical history, AE, or other. |
| Physical examination:oral | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline oral appearance examination, categorized as medical history, AE, or other. |
| Physical examination:throat | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in throat examination, categorized as medical history, AE, or other. |
| Physical examination:neck | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in neck examination, categorized as medical history, AE, or other. |
| Physical examination:heart | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in heart examination, categorized as medical history, AE, or other. |
| Physical examination:lungs | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in lungs examination, categorized as medical history, AE, or other. |
| Physical examination: extremities | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in extremities examination, categorized as medical history, AE, or other. |
| Physical examination: neuromuscular | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in neuromuscular examination, categorized as medical history, AE, or other. |
| Physical examination: abdomen | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Clinically significant changes from baseline in abdomen examination, categorized as medical history, AE, or other. |
| Clinical laboratory tests: hematology | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes in hematology parameters, including eosinophil percentage, basophil percentage, neutrophil percentage, lymphocyte percentage, monocyte percentage, eosinophil count, basophil count, neutrophil count, lymphocyte count, monocyte count, white blood cell count, red blood cell count, platelet count, hematocrit, and hemoglobin, findings are reported as presence or absence of clinically significant change from baseline. |
| Clinical laboratory tests: urinalysis | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes in urinalysis parameters, including white blood cells, red blood cells, pH, protein, glucose, and ketones. This outcome is not measured on a scale; findings are reported as presence or absence of clinically significant change from baseline. |
| Clinical laboratory tests: fecal occult blood | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes in fecal occult blood test results. Qualitative test; findings are reported as presence or absence of clinically significant change from baseline. (negative to positive shift, or vice versa) |
| Clinical laboratory tests: blood chemistry | From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose) | Changes in blood chemistry parameters, including ALT, AST, alkaline phosphatase, GGT, LDH, glucose, total protein, albumin, total bilirubin, direct bilirubin, urea, creatinine, potassium, sodium, amylase, and lipase. Findings are reported as presence or absence of clinically significant change from baseline. |
Countries
China
Contacts
CONTACTXinmin Yun, Ph.D
CONTACTBing Yang, M.Sc
PRINCIPAL_INVESTIGATORZhongyuan Xu, Ph.D.
Nanfang Hospital, Southern Medical University
Outcome results
None listed