Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20241578 | Registry Identifier | Drug Clinical Trial Registration and Information Disclosure Platform, Center for Drug Evaluation, NMPA, China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: JL18008 1 μg/kg | Experimental | Single intramuscular injection of JL18008 at 1 μg/kg. |
|
| Arm 2: Placebo (for 1 μg/kg group) | Placebo Comparator | Single intramuscular injection of placebo (JL18008 buffer). |
|
| Arm 3: JL18008 5 μg/kg | Experimental | Single intramuscular injection of JL18008 at 5 μg/kg. |
|
| Arm 4: Placebo (for 5 μg/kg group) | Placebo Comparator | Single intramuscular injection of placebo. |
|
| Arm 5: JL18008 10 μg/kg | Experimental | Single intramuscular injection of JL18008 at 10 μg/kg. |
|
| Arm 6: Placebo (for 10 μg/kg group) | Placebo Comparator | Single intramuscular injection of placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JL18008 1 μg/kg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 56 days |
| Change from Baseline in Neutrophil Count (NEUT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Arm 7: JL18008 20 μg/kg | Experimental | Single intramuscular injection of JL18008 at 20 μg/kg. |
|
| Arm 8: Placebo (for 20 μg/kg group) | Placebo Comparator | Single intramuscular injection of placebo. |
|
| Arm 9: JL18008 40 μg/kg | Experimental | Single intramuscular injection of JL18008 at 40 μg/kg. |
|
| Arm 10: Placebo (for 40 μg/kg group) | Placebo Comparator | Single intramuscular injection of placebo. |
|
| Arm 11: JL18008 70 μg/kg | Experimental | Single intramuscular injection of JL18008 at 70 μg/kg. |
|
| Arm 12: Placebo (for 70 μg/kg group) | Placebo Comparator | Single intramuscular injection of placebo. |
|
| JL18008 5 μg/kg | Drug | 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. |
|
| JL18008 10 μg/kg | Drug | 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. |
|
| JL18008 20 μg/kg | Drug | 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. |
|
| JL18008 40 μg/kg | Drug | 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. |
|
| JL18008 70 μg/kg | Drug | 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. |
|
| 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 | 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. |
|
| Placebo (for 10 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 10 μg/kg. |
|
| Placebo (for 20 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 20 μg/kg. |
|
| Placebo (for 40 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 40 μg/kg. |
|
| Placebo (for 70 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 70 μg/kg. |
|
Change from baseline in neutrophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 56 days |
| Change from Baseline in Alanine Aminotransferase (ALT) | Change from Baseline in Alanine Aminotransferase (ALT) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 56 days |
| Change from Baseline in Activated Partial Thromboplastin Time (APTT) | Change from Baseline in Activated Partial Thromboplastin Time (APTT) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | Up to 168 hours after first dose |
| Apparent Clearance (CL/F) - Single Dose | Dose divided by AUC₀-∞. Measured in L/h. | Up to 672 hours after first dose |
| Apparent Volume of Distribution (Vz/F) - Single Dose | Dose divided by (λz × AUC₀-∞). Measured in L. | 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. | 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⁺. | 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⁺. | 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. | Up to 672 hours (28 days) |
| Change from Baseline in Serum Interleukin-4 (IL-4) Level | Change from baseline in serum IL-4 level. Measured in pg/mL. Same time points as IL-2. | Up to 672 hours (28 days) |
| Change from Baseline in Serum Interleukin-6 (IL-6) Level | Change from baseline in serum IL-6 level. Measured in pg/mL. Same time points as IL-2. | Up to 672 hours (28 days) |
| Change from Baseline in Serum Interleukin-8 (IL-8) Level | Change from baseline in serum IL-8 level. Measured in pg/mL. Same time points as IL-2. | Up to 672 hours (28 days) |
| Change from Baseline in Serum Interleukin-10 (IL-10) Level | Change from baseline in serum IL-10 level. Measured in pg/mL. Same time points as IL-2. | Up to 672 hours (28 days) |
| Change from Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Level | Change from baseline in serum TNF-α level. Measured in pg/mL. Same time points as IL-2. | Up to 672 hours (28 days) |
| Change from Baseline in Serum Interferon-gamma (IFN-γ) Level | Change from baseline in serum IFN-γ level. Measured in pg/mL. Same time points as IL-2. | Up to 672 hours (28 days) |
| Number of Participants with Anti-Drug Antibodies (ADA) | 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. | Up to 56 days |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074584 | WW Domain-Containing Oxidoreductase |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003710 | Demography |
| D011154 | Population Characteristics |
Not provided
Not provided