HIV Infections
Conditions
Brief summary
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.
Interventions
DRUGJL18008 1 μg/kg
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.
DRUGJL18008 5 μg/kg
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 5 μg/kg.
DRUGJL18008 10 μg/kg
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 10 μg/kg.
DRUGJL18008 20 μg/kg
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 20 μg/kg.
DRUGJL18008 40 μg/kg
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 40 μg/kg.
DRUGJL18008 70 μg/kg
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 70 μg/kg.
DRUGPlacebo (for 1 μg/kg Group)
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.
DRUGPlacebo (for 5 μg/kg Group)
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 5 μg/kg.
DRUGPlacebo (for 10 μg/kg Group)
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 10 μg/kg.
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 20 μg/kg.
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 40 μg/kg.
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 70 μg/kg.
Sponsors
Jecho Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0 | Up to 56 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in White Blood Cell Count (WBC) | Up to 56 days | 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. |
| Change from Baseline in Neutrophil Count (NEUT) | Up to 56 days | Change from baseline in neutrophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Eosinophil Count (EOS) | Up to 56 days | Change from baseline in eosinophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Basophil Count (BASO) | Up to 56 days | Change from baseline in basophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Lymphocyte Count (LYMPH) | Up to 56 days | Change from baseline in lymphocyte count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Red Blood Cell Count (RBC) | Up to 56 days | 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. |
| Change from Baseline in Hemoglobin (HGB) | Up to 56 days | Change from baseline in hemoglobin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Platelet Count (PLT) | Up to 56 days | Change from baseline in platelet count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Hematocrit (HCT) | Up to 56 days | Change from baseline in hematocrit. Measured as a percentage (%). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Total Bilirubin (TBIL) | Up to 56 days | Change from baseline in total bilirubin. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Total Protein (TP) | Up to 56 days | Change from baseline in total protein. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Albumin (ALB) | Up to 56 days | Change from baseline in albumin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Alanine Aminotransferase (ALT) | Up to 56 days | Change from Baseline in Alanine Aminotransferase (ALT) |
| Change from Baseline in Aspartate Aminotransferase (AST) | Up to 56 days | Change from baseline in aspartate aminotransferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Gamma-Glutamyl Transferase (γ-GT) | Up to 56 days | Change from baseline in gamma-glutamyl transferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Creatinine (Cr) | Up to 56 days | Change from baseline in creatinine. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Total Cholesterol (TCHO) | Up to 56 days | Change from baseline in total cholesterol. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Triglycerides (TG) | Up to 56 days | Change from baseline in triglycerides. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Blood Urea Nitrogen (BUN)/Urea | Up to 56 days | Change from baseline in blood urea nitrogen. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Alkaline Phosphatase (ALP) | Up to 56 days | Change from baseline in alkaline phosphatase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Blood Glucose (GLU) | Up to 56 days | Change from baseline in blood glucose. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Serum Phosphorus (Pi) | Up to 56 days | Change from baseline in serum phosphorus. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Serum Sodium (Na⁺) | Up to 56 days | Change from baseline in serum sodium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Serum Potassium (K⁺) | Up to 56 days | Change from baseline in serum potassium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Serum Calcium (Ca²⁺) | Up to 56 days | Change from baseline in serum calcium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Serum Magnesium (Mg²⁺) | Up to 56 days | Change from baseline in serum magnesium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Serum Chloride (Cl-) | Up to 56 days | Change from baseline in serum chloride. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in International Normalized Ratio (INR) | Up to 56 days | Change from baseline in international normalized ratio. Unitless ratio. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Activated Partial Thromboplastin Time (APTT) | Up to 56 days | Change from Baseline in Activated Partial Thromboplastin Time (APTT) |
| Change from Baseline in Prothrombin Time (PT) | Up to 56 days | Change from baseline in prothrombin time. Measured in seconds. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in Fibrinogen (FIB) | Up to 56 days | Change from baseline in fibrinogen. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56. |
| Change from Baseline in ECG Parameter: QTcF Interval | Up to 56 days | 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. |
| Change from Baseline in Systolic Blood Pressure (SBP) | Up to 56 days | 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. |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Up to 56 days | 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. |
| Change from Baseline in Pulse Rate | Up to 56 days | 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. |
| Peak Plasma Concentration (Cmax) - Single Dose | Up to 672 hours after first 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 to Reach Peak Plasma Concentration (Tmax) - Single Dose | Up to 672 hours after first dose | Time to reach maximum observed plasma concentration. Measured in hours (h). Same time points as Cmax. |
| Elimination Half-Life (t½) - Single Dose | Up to 672 hours after first dose | Elimination half-life calculated as ln(2)/λz. Measured in hours (h). |
| Area Under the Curve from Time 0 to Last Measurable Concentration (AUC₀-ₗₐₛₜ) - Single Dose | Up to 672 hours after first dose | AUC using linear trapezoidal rule. Measured in h·pg/mL. |
| Area Under the Curve from Time 0 to Infinity (AUC₀-∞) - Single Dose | Up to 672 hours after first dose | Extrapolated AUC. Measured in h·pg/mL. |
| Area Under the Curve from Time 0 to 168 Hours (AUC₀-₁₆₈ₕ) - Single Dose | Up to 168 hours after first dose | AUC from 0 to 168 hours post-dose. Measured in h·pg/mL. |
| Apparent Clearance (CL/F) - Single Dose | Up to 672 hours after first dose | Dose divided by AUC₀-∞. Measured in L/h. |
| Apparent Volume of Distribution (Vz/F) - Single Dose | Up to 672 hours after first dose | Dose divided by (λz × AUC₀-∞). Measured in L. |
| Change from Baseline in CD4⁺ T Cell Count | Up to 56 days | 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. |
| Change from Baseline in CD8⁺ T Cell Count | Up to 56 days | Change from baseline in absolute CD8⁺ T cell count. Measured in cells/μL. Same time points as CD4⁺. |
| Change from Baseline in CD4/CD8 T Cell Ratio | Up to 56 days | Change from baseline in the ratio of CD4⁺ to CD8⁺ T cells. Unitless ratio. Same time points as CD4⁺. |
| Change from Baseline in Serum Interleukin-2 (IL-2) Level | Up to 672 hours (28 days) | 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. |
| Change from Baseline in Serum Interleukin-4 (IL-4) Level | Up to 672 hours (28 days) | Change from baseline in serum IL-4 level. Measured in pg/mL. Same time points as IL-2. |
| Change from Baseline in Serum Interleukin-6 (IL-6) Level | Up to 672 hours (28 days) | Change from baseline in serum IL-6 level. Measured in pg/mL. Same time points as IL-2. |
| Change from Baseline in Serum Interleukin-8 (IL-8) Level | Up to 672 hours (28 days) | Change from baseline in serum IL-8 level. Measured in pg/mL. Same time points as IL-2. |
| Change from Baseline in Serum Interleukin-10 (IL-10) Level | Up to 672 hours (28 days) | Change from baseline in serum IL-10 level. Measured in pg/mL. Same time points as IL-2. |
| Change from Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Level | Up to 672 hours (28 days) | Change from baseline in serum TNF-α level. Measured in pg/mL. Same time points as IL-2. |
| Change from Baseline in Serum Interferon-gamma (IFN-γ) Level | Up to 672 hours (28 days) | Change from baseline in serum IFN-γ level. Measured in pg/mL. Same time points as IL-2. |
| Number of Participants with Anti-Drug Antibodies (ADA) | Up to 56 days | Incidence of anti-drug antibodies (ADA) against JL18008. For ADA-positive participants, titers and neutralizing antibodies (Nab) will be assessed. Assessed at baseline and at 168, 336, 504, 672, 1320 hours post-dose. |
Countries
China
Outcome results
None listed