To Evaluate the Safety of JL18008

Jecho Biopharmaceuticals Co., Ltd.40 enrolled

Overview

This study is being conducted in healthy adult volunteers to evaluate the safety and tolerability of a single injection of an investigational drug called JL18008. The study also examines how the body processes the drug and how it affects immune cells. Participants receive one intramuscular injection of either JL18008 at one of six dose levels (1, 5, 10, 20, 40, or 70 μg/kg) or a placebo (an inactive substance). The study is randomized, double-blind, and placebo-controlled, meaning participants and study staff do not know who receives the active drug or placebo. Blood samples are collected over 56 days to measure drug levels, immune cell counts (such as CD4⁺ T cells), and any antibodies that may form against the drug. The goal is to find a safe dose that can be tested in future studies of people with HIV who have low CD4⁺ T cells despite antiviral treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

HIV Infections

Interventions

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 1 μg/kg.

Placebo (for 1 μg/kg Group)DRUG

JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 1 μg/kg.

Placebo (for 5 μg/kg Group)DRUG

Placebo (for 10 μg/kg Group)DRUG

Placebo (for 20 μg/kg Group)DRUG

Placebo (for 40 μg/kg Group)DRUG

Placebo (for 70 μg/kg Group)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent. 2. Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests (hematology, urinalysis, serum chemistry, infectious disease screening, coagulation) are normal or have no clinically significant abnormality. 3. Male or female, age 18 to 55 years inclusive. 4. Body weight: male ≥50.0 kg, female ≥45.0 kg. Body mass index (BMI) between 18.0 and 26.0 kg/m² inclusive. BMI = weight (kg) / height (m)². 5. No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease. 6. No plans for pregnancy within 6 months, and agreement to use effective contraception with their partner from screening until 3 months after the study completion. No donation of sperm or eggs during this period. Exclusion Criteria: 1. Any history of allergic disease, or food or drug allergy, that in the investigator's opinion makes the subject unsuitable for inclusion. 2. Lactating women; women of childbearing potential with menstrual disorders within 90 days before dosing; women of childbearing potential who had unprotected intercourse with a male partner within 28 days before dosing. 3. Participation in any clinical trial of an investigational drug within 90 days before dosing, or still within the safety washout period of a previous trial on the day of dosing. 4. Non-physiological blood loss of ≥200 mL (including trauma, blood draw, blood donation) within 60 days before dosing, or plan to donate blood during the study or within 30 days after dosing. 5. Any major illness considered clinically significant by the investigator within 90 days before dosing. 6. Major surgery within 60 days before dosing, or any surgery within 28 days before dosing. 7. Fever or infectious illness within 28 days before dosing. 8. Use of any medication (including prescription, non-prescription, herbal, or dietary supplements) within 14 days before dosing. 9. Vaccination within 1 month before dosing, or plan to receive vaccination during the study period. 10. History or dependence of alcohol or drug abuse, or drug use, or a positive urine drug screen at screening. Alcohol abuse defined as average weekly intake \>21 standard alcohol units. One standard unit contains 14 g of alcohol (e.g., 360 mL of 5% beer, 45 mL of 40% spirits, or 120 mL of 12% wine). 11. Daily smoking of more than 5 cigarettes within 3 months before screening, or unable to refrain from smoking during the study. 12. Vital signs at screening meeting any of the following: systolic blood pressure \<90 mmHg or \>140 mmHg; diastolic blood pressure \<50 mmHg or \>90 mmHg; pulse rate \<50 beats/min or \>100 beats/min. 13. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis antibody. 14. Clinically evident gastrointestinal, hepatic, or renal abnormality that, in the investigator's opinion, may affect drug transport, absorption, distribution, metabolism, or excretion. 15. Any other condition that, in the investigator's judgment, might affect the study results or interfere with the subject's participation throughout the study, including but not limited to other medical history (e.g., psychiatric disorder), abnormalities in vital signs, physical examination, electrocardiogram, or clinical laboratory tests.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). AEs graded according to NCI CTCAE version 5.0. Assessed from Day 1 through Day 56.

Time frame: Up to 56 days

Secondary Outcomes

Change from Baseline in White Blood Cell Count (WBC)

Change from baseline in white blood cell count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Neutrophil Count (NEUT)

Change from baseline in neutrophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Eosinophil Count (EOS)

Change from baseline in eosinophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Basophil Count (BASO)

Change from baseline in basophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Lymphocyte Count (LYMPH)

Change from baseline in lymphocyte count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Red Blood Cell Count (RBC)

Change from baseline in red blood cell count. Measured in 10¹²/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Hemoglobin (HGB)

Change from baseline in hemoglobin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Platelet Count (PLT)

Change from baseline in platelet count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Hematocrit (HCT)

Change from baseline in hematocrit. Measured as a percentage (%). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Total Bilirubin (TBIL)

Change from baseline in total bilirubin. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Total Protein (TP)

Change from baseline in total protein. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Albumin (ALB)

Change from baseline in albumin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Alanine Aminotransferase (ALT)

Time frame: Up to 56 days

Change from Baseline in Aspartate Aminotransferase (AST)

Change from baseline in aspartate aminotransferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Gamma-Glutamyl Transferase (γ-GT)

Change from baseline in gamma-glutamyl transferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Creatinine (Cr)

Change from baseline in creatinine. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Total Cholesterol (TCHO)

Change from baseline in total cholesterol. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Triglycerides (TG)

Change from baseline in triglycerides. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Blood Urea Nitrogen (BUN)/Urea

Change from baseline in blood urea nitrogen. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Alkaline Phosphatase (ALP)

Change from baseline in alkaline phosphatase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Blood Glucose (GLU)

Change from baseline in blood glucose. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Serum Phosphorus (Pi)

Change from baseline in serum phosphorus. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Serum Sodium (Na⁺)

Change from baseline in serum sodium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Serum Potassium (K⁺)

Change from baseline in serum potassium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Serum Calcium (Ca²⁺)

Change from baseline in serum calcium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Serum Magnesium (Mg²⁺)

Change from baseline in serum magnesium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Serum Chloride (Cl-)

Change from baseline in serum chloride. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in International Normalized Ratio (INR)

Change from baseline in international normalized ratio. Unitless ratio. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Activated Partial Thromboplastin Time (APTT)

Time frame: Up to 56 days

Change from Baseline in Prothrombin Time (PT)

Change from baseline in prothrombin time. Measured in seconds. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Fibrinogen (FIB)

Change from baseline in fibrinogen. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in ECG Parameter: QTcF Interval

Change from baseline in the QT interval corrected for heart rate using Fridericia's formula (QTcF). Measured in milliseconds (ms). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Systolic Blood Pressure (SBP)

Change from baseline in systolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Diastolic Blood Pressure (DBP)

Change from baseline in diastolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.

Time frame: Up to 56 days

Change from Baseline in Pulse Rate

Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.

Time frame: Up to 56 days

Peak Plasma Concentration (Cmax) - Single Dose

Maximum observed plasma concentration following single intramuscular injection. Measured in pg/mL. Assessed at pre-dose and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.

Time frame: Up to 672 hours after first dose

Time to Reach Peak Plasma Concentration (Tmax) - Single Dose

Time to reach maximum observed plasma concentration. Measured in hours (h). Same time points as Cmax.

Time frame: Up to 672 hours after first dose

Elimination Half-Life (t½) - Single Dose

Elimination half-life calculated as ln(2)/λz. Measured in hours (h).

Time frame: Up to 672 hours after first dose

Area Under the Curve from Time 0 to Last Measurable Concentration (AUC₀-ₗₐₛₜ) - Single Dose

AUC using linear trapezoidal rule. Measured in h·pg/mL.

Time frame: Up to 672 hours after first dose

Area Under the Curve from Time 0 to Infinity (AUC₀-∞) - Single Dose

Extrapolated AUC. Measured in h·pg/mL.

Time frame: Up to 672 hours after first dose

Area Under the Curve from Time 0 to 168 Hours (AUC₀-₁₆₈ₕ) - Single Dose

AUC from 0 to 168 hours post-dose. Measured in h·pg/mL.

Time frame: Up to 168 hours after first dose

Apparent Clearance (CL/F) - Single Dose

Dose divided by AUC₀-∞. Measured in L/h.

Time frame: Up to 672 hours after first dose

Apparent Volume of Distribution (Vz/F) - Single Dose

Dose divided by (λz × AUC₀-∞). Measured in L.

Time frame: Up to 672 hours after first dose

Change from Baseline in CD4⁺ T Cell Count

Change from baseline in absolute CD4⁺ T cell count. Measured in cells/μL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1320 hours post-dose.

Time frame: Up to 56 days

Change from Baseline in CD8⁺ T Cell Count

Change from baseline in absolute CD8⁺ T cell count. Measured in cells/μL. Same time points as CD4⁺.

Time frame: Up to 56 days

Change from Baseline in CD4/CD8 T Cell Ratio

Change from baseline in the ratio of CD4⁺ to CD8⁺ T cells. Unitless ratio. Same time points as CD4⁺.

Time frame: Up to 56 days

Change from Baseline in Serum Interleukin-2 (IL-2) Level

Change from baseline in serum IL-2 level. Measured in pg/mL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.