A Phase 1 interventional study of ADB116 for Injection and Placebo for ADB116 for Injection in Healthy Adult Participants, sponsored by Jiangsu Aidea Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Jiangsu Aidea Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
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A Phase I Study of ADB116 for Injection in Healthy Chinese Adults. This study aims as follows:
Primary Objective:
Secondary Objective:
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.
Jiangsu Aidea Pharmaceutical Group Co., Ltd. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ADB116 for Injection 0.03mg/kg, single intravenous bolus injection
Drug: ADB116 for Injection
ADB116 for Injection 0.06mg/kg, single intravenous bolus injection
Drug: ADB116 for Injection · Drug: Placebo for ADB116 for Injection
ADB116 for Injection 0.12mg/kg, single intravenous bolus injection
Drug: ADB116 for Injection · Drug: Placebo for ADB116 for Injection
ADB116 for Injection 0.18mg/kg, single intravenous bolus injection
Drug: ADB116 for Injection · Drug: Placebo for ADB116 for Injection
ADB116 for Injection 0.24 mg/kg， single intravenous bolus injection
Drug: ADB116 for Injection · Drug: Placebo for ADB116 for Injection
ADB116 for Injection 0.09mg/kg, single intravenous bolus injection
Drug: ADB116 for Injection · Drug: Placebo for ADB116 for Injection
ADB116 for Injection, single intravenous bolus injection
Also known as: ADB116
Matching placebo, single intravenous bolus injection
Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection
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.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters：Cmax
Cmax is defined as the highest concentration of the drug reached in the body (usually in plasma, whole blood, or serum) after administration.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters： AUC0-t
Area under the plasma concentration-time curve from time zero to the last measurable concentration
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters： AUC0-∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters：t1/2
The time required for the concentration of a drug in the body (typically in plasma) to decrease by one-half.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters：Vz/F
The theoretical volume in which the total amount would need to be uniformly distributed to produce the observed plasma concentration
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters：CL/F
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.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters：λz
Terminal elimination rate constant
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters：percentage of AUC extrapolated (AUC_%Extrap)
Percentage of AUCinf due to extrapolation from Tlast to infinity
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters： MRT0-t
Mean residence time from time zero to the last measurable concentration
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Pharmacokinetic (PK) parameters： MRT0-∞
Mean residence time from time zero extrapolated to infinity
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Coagulation function parameters：thrombin time (TT)
Changes from baseline in thrombin time (TT)
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Coagulation function parameters：activated partial thromboplastin time (APTT)
Changes from baseline in activated partial thromboplastin time (APTT)
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Coagulation function parameters：prothrombin time (PT)
Changes from baseline in prothrombin time (PT)
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Coagulation function parameters：fibrinogen (FIB)
Changes from baseline in fibrinogen (FIB)
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Coagulation function parameters：fibrin/fibrinogen degradation products (FDP)
Changes from baseline in fibrin/fibrinogen degradation products (FDP)
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Coagulation function parameters：plasma D-dimer
Changes from baseline in plasma D-dimer
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Injection site reactions
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.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Electrocardiogram (ECG): heart rate
Heart rate in beat per minute
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Electrocardiogram (ECG): PR interval
Changes in PR interval
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Electrocardiogram (ECG): QRS duration
Changes in QRS duration
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Electrocardiogram (ECG): QTc interval
Changes in QTc interval
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Vital sign: Sitting blood pressure (systolic and diastolic)
Systolic and diastolic blood pressure in millimeters (mm) of mercury (Hg)Time
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Vital sign: pulse
Pulse in beat per minute
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Vital sign: temperature
Temperature in degree Celsius
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:skin
Clinically significant changes from baseline in skin examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination: general appearance
Clinically significant changes from baseline in general appearance examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:head
Clinically significant changes from baseline in head examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:eyes
Clinically significant changes from baseline in eyes examination, categorized as medical history, AE, or other
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination: ears
Clinically significant changes from baseline in ears examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:oral
Clinically significant changes from baseline oral appearance examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:throat
Clinically significant changes from baseline in throat examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:neck
Clinically significant changes from baseline in neck examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:heart
Clinically significant changes from baseline in heart examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination:lungs
Clinically significant changes from baseline in lungs examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination: extremities
Clinically significant changes from baseline in extremities examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination: neuromuscular
Clinically significant changes from baseline in neuromuscular examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Physical examination: abdomen
Clinically significant changes from baseline in abdomen examination, categorized as medical history, AE, or other.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Clinical laboratory tests: hematology
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.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Clinical laboratory tests: urinalysis
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.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Clinical laboratory tests: fecal occult blood
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)
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Clinical laboratory tests: blood chemistry
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.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Plan to share: No
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Started May 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
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