HIV InfectionsPhase 1JL18008NCT07629310
To Evaluate the Safety of JL18008
A Phase 1 study testing JL18008 1 μg/kg, JL18008 5 μg/kg and JL18008 10 μg/kg in people with HIV Infections, run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- JL18008 1 μg/kg, JL18008 5 μg/kg and JL18008 10 μg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2024to 5 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent.
- 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.
- Male or female, age 18 to 55 years inclusive.
- 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.
- No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease.
- 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.
Who cannot join
- Any history of allergic disease, or food or drug allergy, that in the investigator's opinion makes the subject unsuitable for inclusion.
- 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.
- 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.
- 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.
- Any major illness considered clinically significant by the investigator within 90 days before dosing.
- Major surgery within 60 days before dosing, or any surgery within 28 days before dosing.
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- Fever or infectious illness within 28 days before dosing.
- Use of any medication (including prescription, non-prescription, herbal, or dietary supplements) within 14 days before dosing.
- Vaccination within 1 month before dosing, or plan to receive vaccination during the study period.
- 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).
- Daily smoking of more than 5 cigarettes within 3 months before screening, or unable to refrain from smoking during the study.
- 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.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis antibody.
- Clinically evident gastrointestinal, hepatic, or renal abnormality that, in the investigator's opinion, may affect drug transport, absorption, distribution, metabolism, or excretion.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study
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.
- Conditions
- HIV Infections
- Being tested
- JL18008 1 μg/kg, JL18008 5 μg/kg, JL18008 10 μg/kg, JL18008 20 μg/kg, JL18008 40 μg/kg
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JL18008 1 μg/kgDrug
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.
JL18008 5 μg/kgDrug
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/kgDrug
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/kgDrug
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/kgDrug
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/kgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: JL18008 1 μg/kg | Experimental | Single intramuscular injection of JL18008 at 1 μg/kg. Receives: Drug: JL18008 1 μg/kg |
| Arm 2: Placebo (for 1 μg/kg group) | Placebo comparator | Single intramuscular injection of placebo (JL18008 buffer). Receives: Drug: Placebo (for 1 μg/kg Group) |
| Arm 3: JL18008 5 μg/kg | Experimental | Single intramuscular injection of JL18008 at 5 μg/kg. Receives: Drug: JL18008 5 μg/kg |
| Arm 4: Placebo (for 5 μg/kg group) | Placebo comparator | Single intramuscular injection of placebo. Receives: Drug: Placebo (for 5 μg/kg Group) |
| Arm 5: JL18008 10 μg/kg | Experimental | Single intramuscular injection of JL18008 at 10 μg/kg. Receives: Drug: JL18008 10 μg/kg |
| Arm 6: Placebo (for 10 μg/kg group) | Placebo comparator | Single intramuscular injection of placebo. Receives: Drug: Placebo (for 10 μg/kg Group) |
| Arm 7: JL18008 20 μg/kg | Experimental | Single intramuscular injection of JL18008 at 20 μg/kg. Receives: Drug: JL18008 20 μg/kg |
| Arm 8: Placebo (for 20 μg/kg group) | Placebo comparator | Single intramuscular injection of placebo. Receives: Drug: Placebo (for 20 μg/kg Group) |
| Arm 9: JL18008 40 μg/kg | Experimental | Single intramuscular injection of JL18008 at 40 μg/kg. Receives: Drug: JL18008 40 μg/kg |
| Arm 10: Placebo (for 40 μg/kg group) | Placebo comparator | Single intramuscular injection of placebo. Receives: Drug: Placebo (for 40 μg/kg Group) |
| Arm 11: JL18008 70 μg/kg | Experimental | Single intramuscular injection of JL18008 at 70 μg/kg. Receives: Drug: JL18008 70 μg/kg |
| Arm 12: Placebo (for 70 μg/kg group) | Placebo comparator | Single intramuscular injection of placebo. Receives: Drug: Placebo (for 70 μg/kg Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 56 days
Secondary outcomes (54)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 56 days
Change from Baseline in Alanine Aminotransferase (ALT)
Change from Baseline in Alanine Aminotransferase (ALT)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 56 days
Change from Baseline in Activated Partial Thromboplastin Time (APTT)
Change from Baseline in Activated Partial Thromboplastin Time (APTT)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 168 hours after first dose
Apparent Clearance (CL/F) - Single Dose
Dose divided by AUC₀-∞. Measured in L/h.
Measured: Up to 672 hours after first dose
Apparent Volume of Distribution (Vz/F) - Single Dose
Dose divided by (λz × AUC₀-∞). Measured in L.
Measured: 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.
Measured: 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⁺.
Measured: 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⁺.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start13 Jun 2024
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jecho Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629310
- Sponsor's protocol ID
- JL18008-HV/HIV INR-101（Ia）
- Other IDs
- CTR20241578
- Acronym
- JL18008
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 11 Jun 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study
- ClinicalTrials.gov ID
- NCT07629310
- Acronym / sponsor ID
- JL18008 / JL18008-HV/HIV INR-101（Ia）
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jecho Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 5 Jun 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Arm 1: JL18008 1 μg/kg | Experimental | Drug: JL18008 1 μg/kgSingle intramuscular injection of JL18008 at 1 μg/kg. |
| Arm 2: Placebo (for 1 μg/kg group) | Placebo comparator | Drug: Placebo (for 1 μg/kg Group)Single intramuscular injection of placebo (JL18008 buffer). |
| Arm 3: JL18008 5 μg/kg | Experimental | Drug: JL18008 5 μg/kgSingle intramuscular injection of JL18008 at 5 μg/kg. |
| Arm 4: Placebo (for 5 μg/kg group) | Placebo comparator | Drug: Placebo (for 5 μg/kg Group)Single intramuscular injection of placebo. |
| Arm 5: JL18008 10 μg/kg | Experimental | Drug: JL18008 10 μg/kgSingle intramuscular injection of JL18008 at 10 μg/kg. |
| Arm 6: Placebo (for 10 μg/kg group) | Placebo comparator | Drug: Placebo (for 10 μg/kg Group)Single intramuscular injection of placebo. |
| Arm 7: JL18008 20 μg/kg | Experimental | Drug: JL18008 20 μg/kgSingle intramuscular injection of JL18008 at 20 μg/kg. |
| Arm 8: Placebo (for 20 μg/kg group) | Placebo comparator | Drug: Placebo (for 20 μg/kg Group)Single intramuscular injection of placebo. |
| Arm 9: JL18008 40 μg/kg | Experimental | Drug: JL18008 40 μg/kgSingle intramuscular injection of JL18008 at 40 μg/kg. |
| Arm 10: Placebo (for 40 μg/kg group) | Placebo comparator | Drug: Placebo (for 40 μg/kg Group)Single intramuscular injection of placebo. |
| Arm 11: JL18008 70 μg/kg | Experimental | Drug: JL18008 70 μg/kgSingle intramuscular injection of JL18008 at 70 μg/kg. |
| Arm 12: Placebo (for 70 μg/kg group) | Placebo comparator | Drug: Placebo (for 70 μg/kg Group)Single intramuscular injection of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent.
- 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.
- Male or female, age 18 to 55 years inclusive.
- 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.
- No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease.
Key exclusion criteria (15 listed)
- Any history of allergic disease, or food or drug allergy, that in the investigator's opinion makes the subject unsuitable for inclusion.
- 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.
- 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.
- 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.
- Any major illness considered clinically significant by the investigator within 90 days before dosing.
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 |
|---|---|---|
| JL18008 1 μg/kgRecombinant 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. | Drug | Arm 1: JL18008 1 μg/kg |
| JL18008 5 μg/kgRecombinant 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. | Drug | Arm 3: JL18008 5 μg/kg |
| JL18008 10 μg/kgRecombinant 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. | Drug | Arm 5: JL18008 10 μg/kg |
| JL18008 20 μg/kgRecombinant 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. | Drug | Arm 7: JL18008 20 μg/kg |
| JL18008 40 μg/kgRecombinant 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. | Drug | Arm 9: JL18008 40 μg/kg |
| JL18008 70 μg/kgRecombinant 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. | Drug | Arm 11: JL18008 70 μg/kg |
| Placebo (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. | Drug | Arm 2: Placebo (for 1 μg/kg group) |
| Placebo (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. | Drug | Arm 4: Placebo (for 5 μg/kg group) |
| Placebo (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. | Drug | Arm 6: Placebo (for 10 μg/kg group) |
| Placebo (for 20 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 20 μg/kg. | Drug | Arm 8: Placebo (for 20 μg/kg group) |
| Placebo (for 40 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 40 μg/kg. | Drug | Arm 10: Placebo (for 40 μg/kg group) |
| Placebo (for 70 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 70 μg/kg. | Drug | Arm 12: Placebo (for 70 μg/kg group) |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0
Time frame: 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.
54 secondary outcomes
Change from Baseline in White Blood Cell Count (WBC)
Time frame: Up to 56 days
Change from Baseline in Neutrophil Count (NEUT)
Time frame: Up to 56 days
Change from Baseline in Eosinophil Count (EOS)
Time frame: Up to 56 days
Change from Baseline in Basophil Count (BASO)
Time frame: Up to 56 days
Change from Baseline in Lymphocyte Count (LYMPH)
Time frame: Up to 56 days
Change from Baseline in Red Blood Cell Count (RBC)
Time frame: Up to 56 days
Change from Baseline in Hemoglobin (HGB)
Time frame: Up to 56 days
Change from Baseline in Platelet Count (PLT)
Time frame: Up to 56 days
Change from Baseline in Hematocrit (HCT)
Time frame: Up to 56 days
Change from Baseline in Total Bilirubin (TBIL)
Time frame: Up to 56 days
Change from Baseline in Total Protein (TP)
Time frame: Up to 56 days
Change from Baseline in Albumin (ALB)
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)
Time frame: Up to 56 days
Change from Baseline in Gamma-Glutamyl Transferase (γ-GT)
Time frame: Up to 56 days
Change from Baseline in Creatinine (Cr)
Time frame: Up to 56 days
Change from Baseline in Total Cholesterol (TCHO)
Time frame: Up to 56 days
Change from Baseline in Triglycerides (TG)
Time frame: Up to 56 days
Change from Baseline in Blood Urea Nitrogen (BUN)/Urea
Time frame: Up to 56 days
Change from Baseline in Alkaline Phosphatase (ALP)
Time frame: Up to 56 days
Change from Baseline in Blood Glucose (GLU)
Time frame: Up to 56 days
Change from Baseline in Serum Phosphorus (Pi)
Time frame: Up to 56 days
Change from Baseline in Serum Sodium (Na⁺)
Time frame: Up to 56 days
Change from Baseline in Serum Potassium (K⁺)
Time frame: Up to 56 days
Change from Baseline in Serum Calcium (Ca²⁺)
Time frame: Up to 56 days
Change from Baseline in Serum Magnesium (Mg²⁺)
Time frame: Up to 56 days
Change from Baseline in Serum Chloride (Cl-)
Time frame: Up to 56 days
Change from Baseline in International Normalized Ratio (INR)
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)
Time frame: Up to 56 days
Change from Baseline in Fibrinogen (FIB)
Time frame: Up to 56 days
Change from Baseline in ECG Parameter: QTcF Interval
Time frame: Up to 56 days
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Up to 56 days
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Up to 56 days
Change from Baseline in Pulse Rate
Time frame: Up to 56 days
Peak Plasma Concentration (Cmax) - Single Dose
Time frame: Up to 672 hours after first dose
Time to Reach Peak Plasma Concentration (Tmax) - Single Dose
Time frame: Up to 672 hours after first dose
Elimination Half-Life (t½) - Single Dose
Time frame: Up to 672 hours after first dose
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC₀-ₗₐₛₜ) - Single Dose
Time frame: Up to 672 hours after first dose
Area Under the Curve from Time 0 to Infinity (AUC₀-∞) - Single Dose
Time frame: Up to 672 hours after first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 JL18008 1 μg/kg, JL18008 5 μg/kg and JL18008 10 μg/kg in people with HIV Infections, run by Jecho Biopharmaceuticals 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 11 Jun 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0 (time frame: Up to 56 days). 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 11 Jun 2026.