HIV InfectionsPhase 1/2JL18008NCT07579741
A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders
A Phase 1/2 study testing JL18008 20 μg/kg, JL18008 40 μg/kg and JL18008 70 μg/kg in people with HIV Infections, run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- JL18008 20 μg/kg, JL18008 40 μg/kg and JL18008 70 μg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to 28 Sep 2027
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years (inclusive), male or female.
- Body mass index (BMI) 18.0 to 32.0 kg/m² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Receiving combination antiretroviral therapy (cART) for at least 48 months, with a stable antiretroviral regimen for at least 3 months prior to enrollment.
- Maintained HIV-1 RNA below 50 copies/mL for at least 36 months (the earliest test date more than 36 months before enrollment), including transient viral blips (single HIV-1 RNA measurement between 50 and 200 copies/mL after excluding laboratory error). At least two HIV-1 RNA results <50 copies/mL must be available (one may be from screening).
- Immunological non-responder criteria: CD4⁺ T cell count ≤350 cells/μL within 1 year before screening. At least three CD4⁺ T cell counts ≤350 cells/μL within 4 years before enrollment, with intervals of ≥3 months between tests (the third may be from screening).
- Willing to use effective non-pharmacological contraception with partner from screening until 3 months after study completion, and no plan for sperm/egg donation during this period.
- Able to understand and provide written informed consent, and willing to comply with all protocol-specified visits and procedures.
Who cannot join
- Known allergy to the study drug or any of its excipients.
- Receipt of immunosuppressants, immunomodulators, or systemic cytotoxic therapy within 3 months before screening.
- Receipt of hormone therapy within 1 month before screening, except for daily doses ≤10 mg prednisone or equivalent.
- History of severe autoimmune disease requiring systemic treatment or hospitalization, or any active autoimmune disease requiring treatment (including multiple sclerosis).
- History of systemic infection (viral, bacterial, parasitic, or fungal) requiring systemic treatment and/or hospitalization, or other opportunistic infection, within 30 days before screening.
- Active tuberculosis lesion within 30 days before screening.
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- Blood disorders associated with hypersplenism (e.g., thalassemia, hereditary spherocytosis, Gaucher's disease, autoimmune hemolytic anemia) or history of splenectomy.
- Chronic diarrhea.
- Severe cardiovascular disease within 6 months before screening, including myocardial infarction, unstable angina, congestive heart failure (NYHA class ≥II), or arrhythmia requiring medication.
- Uncontrolled hypertension, defined as resting systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg on at least two repeated measurements on different days despite antihypertensive treatment.
- Positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCV-Ab) with detectable HCV-RNA, or active syphilis.
- Any of the following laboratory abnormalities at screening: hemoglobin <90 g/L; neutrophil count <1.5×10⁹/L; platelet count <100×10⁹/L; serum creatinine >1.5× upper limit of normal (ULN); alanine aminotransferase >2.5×ULN; aspartate aminotransferase >2.5×ULN; alkaline phosphatase >2.5×ULN; total bilirubin >1.5×ULN; international normalized ratio >1.5; activated partial thromboplastin time >1.5×ULN.
- Diagnosis of cancer within the screening period.
- Severe neurological or psychiatric disease, or history of seizures.
- History of drug abuse within 3 months before screening, or positive urine drug screen (including morphine, methamphetamine, ketamine, MDMA, THC, cocaine), or history of alcohol abuse.
- Participation in another clinical trial with receipt of investigational drug within 3 months before screening.
- Vaccination within 6 weeks before screening, or plan to receive any vaccination within 1 year after enrollment.
- Pregnancy, positive pregnancy test, or breastfeeding.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical study.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects / HIV Immunological Non-Responders: A Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Study
The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological non-responders (INRs).
Based on the Phase Ia clinical data, three dose groups are planned for the Phase Ib trial: 20, 40, and 70 μg/kg of JL18008. Each group is planned to enroll 10 subjects (8 receiving active drug and 2 receiving placebo). All subjects must maintain their original cART regimen unchanged. Subjects in the active treatment groups will receive JL18008 injection in addition to cART, while those in the control group will receive placebo (JL18008 injection buffer) in addition to cART. The dosing regimen is tentatively once weekly (QW) for 4 consecutive weeks, which constitutes one treatment cycle, followed by an observation/follow-up period. The study drug will be administered by intramuscular injection.
- Conditions
- HIV Infections
- Being tested
- JL18008 20 μg/kg, Placebo (for 20 μg/kg Group), JL18008 40 μg/kg, Placebo (for 40 μg/kg Group), JL18008 70 μg/kg
- Keywords
- HIV Infections, Ib, Immunological Non-Responders
- 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 20 μg/kgDrug
Participants receive JL18008 20 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
Placebo (for 20 μg/kg Group)Drug
Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
JL18008 40 μg/kgDrug
Participants receive JL18008 40 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
Placebo (for 40 μg/kg Group)Drug
Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
JL18008 70 μg/kgDrug
Participants receive JL18008 70 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
Placebo (for 70 μg/kg Group)Drug
Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
| Study group | Role | What they receive |
|---|---|---|
| JL18008 20 μg/kg | Experimental | Participants receive JL18008 20 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. Receives: Drug: JL18008 20 μg/kg |
| Placebo (for 20 μg/kg Group) | Placebo comparator | Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. Receives: Drug: Placebo (for 20 μg/kg Group) |
| JL18008 40 μg/kg | Experimental | Participants receive JL18008 40 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. Receives: Drug: JL18008 40 μg/kg |
| Placebo (for 40 μg/kg Group) | Placebo comparator | Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. Receives: Drug: Placebo (for 40 μg/kg Group) |
| JL18008 70 μg/kg | Experimental | Participants receive JL18008 70 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. Receives: Drug: JL18008 70 μg/kg |
| Placebo (for 70 μg/kg Group) | Placebo comparator | Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. 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 DAIDS v2.1
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs). Adverse events are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1. Assessed from first dose up to Week 24.
Measured: Up to 24 weeks
Change from Baseline in Vital Signs: Pulse Rate (bpm)
Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (mmHg)
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Both measured in millimeters of mercury (mmHg). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Change from Baseline in Hematology Parameters
Change from baseline in hematology parameters including white blood cell count (10^9/L), hemoglobin (g/L), platelet count (10^9/L), neutrophil count (10^9/L), lymphocyte count (10^9/L), and red blood cell count (10^12/L). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Change from Baseline in Serum Chemistry Parameters
hange from baseline in serum chemistry parameters including alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), creatinine (μmol/L), triglycerides (mmol/L), total cholesterol (mmol/L), glucose (mmol/L), and electrolytes (Na⁺, K⁺, Cl-, Ca²⁺, Mg²⁺, Pi). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Change from Baseline in Coagulation Parameters
Change from baseline in coagulation parameters including international normalized ratio (INR), activated partial thromboplastin time (APTT, seconds), prothrombin time (PT, seconds), and fibrinogen (g/L). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
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 Weeks 1, 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Secondary outcomes (32)
Proportion of Participants with CD4⁺ T Cell Count Increase ≥100 cells/μL from Baseline
Proportion of participants achieving an increase from baseline in CD4⁺ T cell count of at least 100 cells/μL. Assessed at baseline and Weeks 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Proportion of Participants Achieving CD4⁺ T Cell Count ≥500 cells/μL
Proportion of participants with CD4⁺ T cell count reaching 500 cells/μL or higher. Assessed at Weeks 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 12 Weeks
Proportion of participants with average increase from baseline in CD4⁺ T cell count of at least 100 cells/μL over the first 12 weeks. Assessed from baseline through Week 12.
Measured: Baseline through Week 12
Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 12 Weeks
Proportion of participants with average CD4⁺ T cell count of 500 cells/μL or higher over the first 12 weeks. Assessed from baseline through Week 12.
Measured: Baseline through Week 12
Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 24 Weeks
Proportion of participants with average increase from baseline in CD4⁺ T cell count of at least 100 cells/μL over the 24-week study period. Assessed from baseline through Week 24.
Measured: Baseline through Week 24
Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 24 Weeks
Proportion of participants with average CD4⁺ T cell count of 500 cells/μL or higher over the 24-week study period. Assessed from baseline through Week 24.
Measured: Baseline through Week 24
Change from Baseline in CD4/CD8 T Cell Ratio
Change from baseline in the ratio of CD4⁺ to CD8⁺ T cells. Assessed at baseline and Weeks 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Proportion of Participants with HIV-1 RNA <50 copies/mL
Proportion of participants maintaining HIV-1 RNA below 50 copies/mL. Assessed at Weeks 4, 8, 12, 16, 20, and 24.
Measured: Up to 24 weeks
Number of Participants with Clinical Events
Number of participants experiencing clinical events including opportunistic infections, malignancies, and non-AIDS complications (e.g., cardiovascular, renal, hepatic events). Assessed from first dose up to Week 24.
Measured: Up to 24 weeks
Change from Baseline in Serum Cytokine Levels (IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α, IFN-γ)
Change from baseline in serum levels of cytokines. All measured in pg/mL. Assessed at baseline, Days 1, 2, 3, 5, 8, 15, 22, 23, 24, 26, 29, and Weeks 8, 12, 16, 20, 24.
Measured: Up to 24 weeks
Change from Baseline in Lymphocyte Subset Counts (cells/μL)
Change from baseline in absolute counts of lymphocytes, T cells (CD3⁺), CD8⁺ T cells, B cells (CD19⁺), natural killer cells (CD56⁺), and their subsets including memory, naive, regulatory, and activation markers (CD38⁺, HLA-DR⁺, PD-1⁺). Assessed at baseline, Days 1, 2, 3, 5, 8, 15, 22, 23, 24, 26, 29, and Weeks 8, 12, 16, 20, 24.
Measured: Up to 24 weeks
Peak Plasma Concentration (Cmax) - Single Dose
Maximum observed plasma concentration following the first dose. Derived directly from the concentration-time data. Measured in pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Time to Reach Peak Plasma Concentration (Tmax) - Single Dose
Time to reach maximum observed plasma concentration following the first dose. Measured in hours (h). Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Elimination Half-Life (t½) - Single Dose
Elimination half-life following the first dose. Calculated as ln(2)/λz, where λz is the terminal elimination rate constant. Measured in hours (h). Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) - Single Dose
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration following the first dose. Calculated using the linear trapezoidal rule. Measured in h·pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Area Under the Curve from Time 0 to Infinity (AUC0-inf) - Single Dose
Area under the plasma concentration-time curve from time 0 extrapolated to infinity following the first dose. Calculated as AUC0-last + Clast/λz. Measured in h·pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Area Under the Curve from Time 0 to 168 Hours (AUC0-168h) - Single Dose
Area under the plasma concentration-time curve from time 0 to 168 hours following the first dose. Measured in h·pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Apparent Clearance (CL/F) - Single Dose
Apparent total clearance of the drug from plasma following extravascular administration. Calculated as Dose / AUC0-inf. Measured in L/h. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Apparent Volume of Distribution (Vz/F) - Single Dose
Apparent volume of distribution during the terminal phase following extravascular administration. Calculated as Dose / (λz * AUC0-inf). Measured in L. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours post-dose.
Measured: Up to 168 hours after first dose
Steady-State Peak Plasma Concentration (Cmax, ss)
Maximum observed plasma concentration at steady state following the fourth dose (Week 4). Measured in pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Steady-State Time to Reach Peak Plasma Concentration (Tmax, ss)
Time to reach maximum observed plasma concentration at steady state following the fourth dose. Measured in hours (h). Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Steady-State Minimum Plasma Concentration (Cmin, ss)
Minimum observed plasma concentration at steady state following the fourth dose. Measured in pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Steady-State Average Plasma Concentration (Cavg, ss)
Average plasma concentration at steady state over the dosing interval. Calculated as AUC0-tau / τ. Measured in pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Area Under the Curve Over Dosing Interval (AUC0-tau) - Steady State
Area under the plasma concentration-time curve over the dosing interval (168 hours) at steady state. Measured in h·pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Steady-State Area Under the Curve from Time 0 to Infinity (AUC0-inf, ss)
Area under the plasma concentration-time curve from time 0 extrapolated to infinity at steady state. Measured in h·pg/mL. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Steady-State Apparent Clearance (CLss/F)
Apparent total clearance at steady state. Calculated as Dose / AUC0-tau. Measured in L/h. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Steady-State Apparent Volume of Distribution (Vss/F)
Apparent volume of distribution at steady state. Measured in L. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Steady-State Elimination Half-Life (t½, ss)
Elimination half-life at steady state. Measured in hours (h). Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Degree of Fluctuation (DF) - Steady State
Degree of fluctuation at steady state. Calculated as (Cmax, ss - Cmin, ss) / Cavg, ss. No units. Assessed at pre-dose and at 1, 2, 4, 8, 12, 24, 48, 96, and 168 hours after the fourth dose.
Measured: Up to 168 hours after the fourth dose (Week 4)
Accumulation Ratio for Cmax (RacCmax)
Accumulation ratio for peak concentration. Calculated as Cmax, ss / Cmax following first dose. No units. Assessed after first dose and after fourth dose (Week 4).
Measured: From first dose to steady state (Week 4)
Accumulation Ratio for AUC (RacAUC0-tau)
Accumulation ratio for area under the curve. Calculated as AUC0-tau, ss / AUC0-tau following first dose. No units. Assessed after first dose and after fourth dose (Week 4).
Measured: From first dose to steady state (Week 4)
Number of Participants with Anti-Drug Antibodies (ADA)
Number and percentage of participants who develop anti-drug antibodies (ADA) against JL18008. For ADA-positive participants, titers and neutralizing antibody (Nab) status will be assessed. Assessed at baseline, Days 8, 15, 22, 29, and Weeks 8, 12, 16, 20, 24.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start26 May 2026
- Primary completion12 Feb 2027 (estimated)
- Study completion28 Sep 2027 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
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
- NCT07579741
- Sponsor's protocol ID
- JL18008-HV/HIV INR-101
- Acronym
- JL18008
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. The trial data is proprietary and part of a product development program. Data sharing is not planned at this stage of clinical development.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 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 / HIV Immunological Non-Responders: A Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Study
- ClinicalTrials.gov ID
- NCT07579741
- Acronym / sponsor ID
- JL18008 / JL18008-HV/HIV INR-101
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Ib, Immunological Non-Responders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jecho Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- 28 Sep 2027 (estimated)
- First posted
- 12 May 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.
The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological non-responders (INRs).
Based on the Phase Ia clinical data, three dose groups are planned for the Phase Ib trial: 20, 40, and 70 μg/kg of JL18008. Each group is planned to enroll 10 subjects (8 receiving active drug and 2 receiving placebo). All subjects must maintain their original cART regimen unchanged. Subjects in the active treatment groups will receive JL18008 injection in addition to cART, while those in the control group will receive placebo (JL18008 injection buffer) in addition to cART. The dosing regimen is tentatively once weekly (QW) for 4 consecutive weeks, which constitutes one treatment cycle, followed by an observation/follow-up period. The study drug will be administered by intramuscular injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| JL18008 20 μg/kg | Experimental | Drug: JL18008 20 μg/kgParticipants receive JL18008 20 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. |
| Placebo (for 20 μg/kg Group) | Placebo comparator | Drug: Placebo (for 20 μg/kg Group)Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. |
| JL18008 40 μg/kg | Experimental | Drug: JL18008 40 μg/kgParticipants receive JL18008 40 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. |
| Placebo (for 40 μg/kg Group) | Placebo comparator | Drug: Placebo (for 40 μg/kg Group)Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. |
| JL18008 70 μg/kg | Experimental | Drug: JL18008 70 μg/kgParticipants receive JL18008 70 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. |
| Placebo (for 70 μg/kg Group) | Placebo comparator | Drug: Placebo (for 70 μg/kg Group)Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years (inclusive), male or female.
- Body mass index (BMI) 18.0 to 32.0 kg/m² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Receiving combination antiretroviral therapy (cART) for at least 48 months, with a stable antiretroviral regimen for at least 3 months prior to enrollment.
- Maintained HIV-1 RNA below 50 copies/mL for at least 36 months (the earliest test date more than 36 months before enrollment), including transient viral blips (single HIV-1 RNA measurement between 50 and 200 copies/mL after excluding laboratory error). At least two HIV-1 RNA results <50 copies/mL must be available (one may be from screening).
- Immunological non-responder criteria: CD4⁺ T cell count ≤350 cells/μL within 1 year before screening. At least three CD4⁺ T cell counts ≤350 cells/μL within 4 years before enrollment, with intervals of ≥3 months between tests (the third may be from screening).
Key exclusion criteria (19 listed)
- Known allergy to the study drug or any of its excipients.
- Receipt of immunosuppressants, immunomodulators, or systemic cytotoxic therapy within 3 months before screening.
- Receipt of hormone therapy within 1 month before screening, except for daily doses ≤10 mg prednisone or equivalent.
- History of severe autoimmune disease requiring systemic treatment or hospitalization, or any active autoimmune disease requiring treatment (including multiple sclerosis).
- History of systemic infection (viral, bacterial, parasitic, or fungal) requiring systemic treatment and/or hospitalization, or other opportunistic infection, within 30 days before screening.
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 20 μg/kgParticipants receive JL18008 20 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART). | Drug | JL18008 20 μg/kg |
| Placebo (for 20 μg/kg Group)Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART). | Drug | Placebo (for 20 μg/kg Group) |
| JL18008 40 μg/kgParticipants receive JL18008 40 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART). | Drug | JL18008 40 μg/kg |
| Placebo (for 40 μg/kg Group)Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART). | Drug | Placebo (for 40 μg/kg Group) |
| JL18008 70 μg/kgParticipants receive JL18008 70 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART). | Drug | JL18008 70 μg/kg |
| Placebo (for 70 μg/kg Group)Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART). | Drug | Placebo (for 70 μg/kg Group) |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by DAIDS v2.1
Time frame: Up to 24 weeks
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs). Adverse events are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1. Assessed from first dose up to Week 24.
Change from Baseline in Vital Signs: Pulse Rate (bpm)
Time frame: Up to 24 weeks
Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.
Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (mmHg)
Time frame: Up to 24 weeks
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Both measured in millimeters of mercury (mmHg). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.
Change from Baseline in Hematology Parameters
Time frame: Up to 24 weeks
Change from baseline in hematology parameters including white blood cell count (10^9/L), hemoglobin (g/L), platelet count (10^9/L), neutrophil count (10^9/L), lymphocyte count (10^9/L), and red blood cell count (10^12/L). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
Change from Baseline in Serum Chemistry Parameters
Time frame: Up to 24 weeks
hange from baseline in serum chemistry parameters including alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), creatinine (μmol/L), triglycerides (mmol/L), total cholesterol (mmol/L), glucose (mmol/L), and electrolytes (Na⁺, K⁺, Cl-, Ca²⁺, Mg²⁺, Pi). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
Change from Baseline in Coagulation Parameters
Time frame: Up to 24 weeks
Change from baseline in coagulation parameters including international normalized ratio (INR), activated partial thromboplastin time (APTT, seconds), prothrombin time (PT, seconds), and fibrinogen (g/L). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.
Change from Baseline in ECG Parameter: QTcF Interval
Time frame: Up to 24 weeks
Change from baseline in the QT interval corrected for heart rate using Fridericia's formula (QTcF). Measured in milliseconds (ms). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.
32 secondary outcomes
Proportion of Participants with CD4⁺ T Cell Count Increase ≥100 cells/μL from Baseline
Time frame: Up to 24 weeks
Proportion of Participants Achieving CD4⁺ T Cell Count ≥500 cells/μL
Time frame: Up to 24 weeks
Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 12 Weeks
Time frame: Baseline through Week 12
Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 12 Weeks
Time frame: Baseline through Week 12
Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 24 Weeks
Time frame: Baseline through Week 24
Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 24 Weeks
Time frame: Baseline through Week 24
Change from Baseline in CD4/CD8 T Cell Ratio
Time frame: Up to 24 weeks
Proportion of Participants with HIV-1 RNA <50 copies/mL
Time frame: Up to 24 weeks
Number of Participants with Clinical Events
Time frame: Up to 24 weeks
Change from Baseline in Serum Cytokine Levels (IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α, IFN-γ)
Time frame: Up to 24 weeks
Change from Baseline in Lymphocyte Subset Counts (cells/μL)
Time frame: Up to 24 weeks
Peak Plasma Concentration (Cmax) - Single Dose
Time frame: Up to 168 hours after first dose
Time to Reach Peak Plasma Concentration (Tmax) - Single Dose
Time frame: Up to 168 hours after first dose
Elimination Half-Life (t½) - Single Dose
Time frame: Up to 168 hours after first dose
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) - Single Dose
Time frame: Up to 168 hours after first dose
Area Under the Curve from Time 0 to Infinity (AUC0-inf) - Single Dose
Time frame: Up to 168 hours after first dose
Area Under the Curve from Time 0 to 168 Hours (AUC0-168h) - Single Dose
Time frame: Up to 168 hours after first dose
Apparent Clearance (CL/F) - Single Dose
Time frame: Up to 168 hours after first dose
Apparent Volume of Distribution (Vz/F) - Single Dose
Time frame: Up to 168 hours after first dose
Steady-State Peak Plasma Concentration (Cmax, ss)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Steady-State Time to Reach Peak Plasma Concentration (Tmax, ss)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Steady-State Minimum Plasma Concentration (Cmin, ss)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Steady-State Average Plasma Concentration (Cavg, ss)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Area Under the Curve Over Dosing Interval (AUC0-tau) - Steady State
Time frame: Up to 168 hours after the fourth dose (Week 4)
Steady-State Area Under the Curve from Time 0 to Infinity (AUC0-inf, ss)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Steady-State Apparent Clearance (CLss/F)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Steady-State Apparent Volume of Distribution (Vss/F)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Steady-State Elimination Half-Life (t½, ss)
Time frame: Up to 168 hours after the fourth dose (Week 4)
Degree of Fluctuation (DF) - Steady State
Time frame: Up to 168 hours after the fourth dose (Week 4)
Accumulation Ratio for Cmax (RacCmax)
Time frame: From first dose to steady state (Week 4)
Accumulation Ratio for AUC (RacAUC0-tau)
Time frame: From first dose to steady state (Week 4)
Number of Participants with Anti-Drug Antibodies (ADA)
Time frame: Up to 24 weeks
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 6 Aug 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. The trial data is proprietary and part of a product development program. Data sharing is not planned at this stage of clinical development.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JL18008 20 μg/kg, JL18008 40 μg/kg and JL18008 70 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 7 inclusion and 19 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 6 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. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Prof. Taisheng Li (+86-10-69156114, litsh@263.net), or a site near the patient. 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 DAIDS v2.1 (time frame: Up to 24 weeks). The study lists 7 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 6 Aug 2026.