Healthy Adult ParticipantsPhase 1NCT07729839
Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection
A Phase 1 study testing ADB116 for Injection in people with Healthy Adult Participants, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- ADB116 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2026to 18 Mar 2027
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form (ICF) prior to any study procedures and be able to comply with the protocol requirements.
- 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.
- 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).
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Zhongyuan Xu, Ph.D., +86 13926186470, nflcyljd@smu.edu.cn
About this study
Official title: Study of Safety, Tolerability, and Pharmacokinetics of ADB116 for Injection in Healthy Chinese Adults: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Phase I Clinical Trial
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.
Read the 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.
- Conditions
- Healthy Adult Participants
- Being tested
- ADB116 for Injection, Placebo for ADB116 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADB116 for InjectionDrug
Also called ADB116
ADB116 for Injection, single intravenous bolus injection
Placebo for ADB116 for InjectionDrug
Matching placebo, single intravenous bolus injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ADB116 0.03 mg/kg | Experimental | ADB116 for Injection 0.03mg/kg, single intravenous bolus injection Receives: Drug: ADB116 for Injection |
| Cohort 2: ADB116 0.06 mg/kg | Experimental | ADB116 for Injection 0.06mg/kg, single intravenous bolus injection Receives: Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection |
| Cohort 4: ADB116 0.12mg/kg | Experimental | ADB116 for Injection 0.12mg/kg, single intravenous bolus injection Receives: Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection |
| Cohort 5: ADB116 0.18mg/kg | Experimental | ADB116 for Injection 0.18mg/kg, single intravenous bolus injection Receives: Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection |
| Cohort 6: ADB116 0.24 mg/kg | Experimental | ADB116 for Injection 0.24 mg/kg， single intravenous bolus injection Receives: Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection |
| Cohort 3: ADB116 0.09 mg/kg | Experimental | ADB116 for Injection 0.09mg/kg, single intravenous bolus injection Receives: Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Secondary outcomes (31)
Coagulation function parameters：thrombin time (TT)
Changes from baseline in thrombin time (TT)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start31 May 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongyuan Xu, Ph.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729839
- Sponsor's protocol ID
- ADYY-ADB116-101
- Other IDs
- CTR20260342
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety, Tolerability, and Pharmacokinetics of ADB116 for Injection in Healthy Chinese Adults: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT07729839
- Acronym / sponsor ID
- ADYY-ADB116-101
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 18 Mar 2027 (estimated)
- First posted
- 28 Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ADB116 0.03 mg/kg | Experimental | Drug: ADB116 for InjectionADB116 for Injection 0.03mg/kg, single intravenous bolus injection |
| Cohort 2: ADB116 0.06 mg/kg | Experimental | Drug: ADB116 for Injection, Drug: Placebo for ADB116 for InjectionADB116 for Injection 0.06mg/kg, single intravenous bolus injection |
| Cohort 4: ADB116 0.12mg/kg | Experimental | Drug: ADB116 for Injection, Drug: Placebo for ADB116 for InjectionADB116 for Injection 0.12mg/kg, single intravenous bolus injection |
| Cohort 5: ADB116 0.18mg/kg | Experimental | Drug: ADB116 for Injection, Drug: Placebo for ADB116 for InjectionADB116 for Injection 0.18mg/kg, single intravenous bolus injection |
| Cohort 6: ADB116 0.24 mg/kg | Experimental | Drug: ADB116 for Injection, Drug: Placebo for ADB116 for InjectionADB116 for Injection 0.24 mg/kg， single intravenous bolus injection |
| Cohort 3: ADB116 0.09 mg/kg | Experimental | Drug: ADB116 for Injection, Drug: Placebo for ADB116 for InjectionADB116 for Injection 0.09mg/kg, single intravenous bolus injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form (ICF) prior to any study procedures and be able to comply with the protocol requirements.
- 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.
- 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).
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ADB116 for InjectionAlso: ADB116ADB116 for Injection, single intravenous bolus injection | Drug | Cohort 1: ADB116 0.03 mg/kg, Cohort 2: ADB116 0.06 mg/kg, Cohort 3: ADB116 0.09 mg/kg, Cohort 4: ADB116 0.12mg/kg, Cohort 5: ADB116 0.18mg/kg, Cohort 6: ADB116 0.24 mg/kg |
| Placebo for ADB116 for InjectionMatching placebo, single intravenous bolus injection | Drug | Cohort 2: ADB116 0.06 mg/kg, Cohort 3: ADB116 0.09 mg/kg, Cohort 4: ADB116 0.12mg/kg, Cohort 5: ADB116 0.18mg/kg, Cohort 6: ADB116 0.24 mg/kg |
Primary outcome
Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection
Time frame: 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
Time frame: 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
Time frame: 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-∞
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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-∞
Time frame: 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
31 secondary outcomes
Coagulation function parameters：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)
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)
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)
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)
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
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 5 Aug 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.
Zhongyuan Xu, Ph.D. principal investigator
Nanfang Hospital, Southern Medical University
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 ADB116 for Injection in people with Healthy Adult Participants, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
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 4 inclusion and 0 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 5 Aug 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 China. 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 Xinmin Yun, Ph.D (＋86 0514-87752666, yunxm@aidea.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection (time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)). The study lists 11 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 5 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.