HIVPhase 1NCT07443228
Recombinant Human Interleukin-7 (JL18008) for the Treatment of HIV-Infected Immunological Non-Responders
A Phase 1 study testing JL18008 in people with HIV, run by Jecho Biopharmaceuticals Co., Ltd..
Trial summary
JL18008 Injection is designed to improve the immune response in cART-treated HIV-infected immunological non-responders (HIV INRs). The study includes 3 trials： Phase Ia: A randomized, single-blind, placebo-controlled, single-dose escalation study to evaluate the tolerability and safety of JL18008 Injection and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- JL18008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 31 Dec 2030
- Phase
- Phase 1
- 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 between 18 - 65 years old, male or female.
- Body Mass Index (BMI) between 18 - 32 kg/m2, body weight ≥ 50 kg in male and ≥ 45 kg in female.
- On cART for at least 36 months, on stable regimen (no drug or dose changes) for at least 3 months prior to study entry.
- Plasma HIV RNA < 50 copies/mL in last 30 months in minimum two measurements (including the screening measurement) and the two measurements should done within 6 months prior to study entry (note: patients with single blip of detectable viremia during this period will be allowed to participate if the prior and subsequent plasma HIV RNA levels are < 50 copies/mL).
- During 12 months prior to study entry, CD4+ T cell counts > 100 and ≤ 350 cells/µL measured in at least two measurements (including the screening measurement) and the interval between the two measurements should be ≥ 3 months (Note: only one time value of CD4+ T cell count > 350 during this period will be allowed to participate if the previous and subsequent CD4+ T cell count is in the range of > 100 and ≤ 350 cells/µL).
- All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must practice at least one form of barrier birth control (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, other barrier contraception, etc.), during study and 3 months after the study.
- The subject fully understands the requirements of the study and voluntarily signs the ICF.
Who cannot join
- Prior treatment with IL-7 or IL-2.
- Allergy to JL18008 Injection components, e.g. HSA.
- Prior treatment with immunomodulatory agents such as thymosin, immunosuppressive drugs, or cytotoxic chemotherapy within 6 months prior to study entry.
- Any history of generalized psoriasis, Crohn's disease, uveitis, systemic lupus erythematosus (SLE), Hashimoto's thyroiditis or other autoimmune diseases.
- Any history of virus, bacteria, parasites or fungal infection and other opportunistic infections requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
- Active tuberculosis within 30 days prior to study entry.
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- Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia.
- History of splenectomy.
- Any gastrointestinal illness associated with chronic or intermittent diarrhea.
- Severe cardiovascular disease: myocardial infarction, unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association > class II) or cardiac arrhythmia requiring medication within 6 months prior to study entry.
- Hypertension with a resting systolic blood pressure > 140 mmHg or a resting diastolic blood pressure > 90 mmHg despite adequate antihypertensive treatment.
- Hepatitis B Surface Antigen (HBs Ag) positive and/or Hepatitis C virus (HCV) antibody positive and HCV-RNA positive.
- Abnormal clinical laboratory tests results meet any of the following criteria: Hemoglobin (HGB) < 120 g/L for men and < 110 g/L for women; White blood cell (WBC) count < 3.5 × 109/L; neutrophil count (NEUT) < 1.5 × 109/L; Platelet (PLT) count < 125 × 109/L; Creatinine (Cr) > 1.1 × upper limit of normal value (ULN); Alanine aminotransferase (ALT) > 1.1 × ULN; Aspartate aminotransferase (AST) > 1.1 × ULN; Alkaline phosphatase (ALP) > 1.1 × ULN; Total bilirubin (TBIL) >1.1 × ULN; Phosphate level < 2.5 mg/dL; International normalized ratio (INR) > 1.3; Activated partial thromboplastin time (APTT) < 1.5 × ULN.
- Any history of HIV related encephalopathy.
- Diagnosis of cancer within the last 5 years prior to study entry (except skin basal cell or squamous cell carrcinomas, and cutaneous Kaposi's sarcoma not requiring systemic therapy).
- Any history of severe mental disorders or epilepsy.
- History of drug abuse (e.g. heroin, cocaine, and crystal meth, etc.) or alcohol abuse (defined as the daily regular consumption of alcohol exceeding the following standard amount: 570 ml of beer, 750 ml of light beer, 200 ml of red wine or 60 ml of liquor, each containing about 20 g of alcohol) within 3 months prior to study entry and heavy smoker (over 20 cigarettes per day for more than 3 months) within 6 months prior to study entry.
- Treatment with another study drug within 3 months prior to study entry.
- History of vaccination with live attenuated vaccine in 6 weeks prior to study entry or vaccination planed during the study and within 3 months after completion of the study.
- Pregnancy or lactation.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or sponsor physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
About this study
Official title: A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of JL18008 Injection in HIV-Infected Immunological Non-Responders
JL18008 Injection is designed to improve the immune response in cART-treated HIV-infected immunological non-responders (HIV INRs). The study includes 3 trials： Phase Ia: A randomized, single-blind, placebo-controlled, single-dose escalation study to evaluate the tolerability and safety of JL18008 Injection and determine the RED in HIV INRs.
Phase Ib: A randomized, double-blind, placebo-controlled, dose expansion study to evaluate the safety of JL18008 Injection and determine the RP2D in HIV INRs.
Phase II: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JL18008 Injection in HIV INRs.
- Conditions
- HIV
- Being tested
- JL18008
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JL18008Drug
The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.
| Study group | Role | What they receive |
|---|---|---|
| JL18008 i.m. 1 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
| JL18008 i.m. 2 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
| JL18008 i.m. 4 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
| JL18008 i.m. 8 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
| JL18008 i.m. 16 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
| JL18008 i.m. 30 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
| JL18008 i.m. 50 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
| JL18008 i.m. 70 μg/kg | Experimental | The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. Receives: Drug: JL18008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of JL18008
Number of participants with any death.
Measured: 3 months
The safety of JL18008
Number of participants with AEs and SAEs.
Measured: 3 months
The safety of JL18008
Number of participants with discontinuation due to AEs.
Measured: 3 months
Secondary outcomes (16)
To Evaluate the Pharmacokinetics of JL18008
Cmax
Measured: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Tmax
Measured: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
AUC0-inf
Measured: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
t1/2
Measured: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
AUC0-t
Measured: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
CL/F
Measured: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Vz/F
Measured: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Efficacy of Escalating Doses of JL18008
The proportion of subjects whose CD4+ T cell count increases ≥ 100 cells/μL on D28.
The proportion of subjects whose CD4+ T cell count ≥ 400 cells/μL on D28.
Measured: The PD sampling time points are: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168(D8), 240(D11), 336(D15), 504(D22), 672(D29), 1320(D56) and 1992(D84) hours of post-dose.
Immunogenicity
ADA on baseline, D15, and D28. Nab when ADA is positive. The proportion of subjects with ADA and/or Nab positive.
Measured: The samples for ADA assessment will be collected at the following time points: 0.5 hour of pre-dose and 336(D15), 672(D29), 1320(D56) and 1992(D84) hours of post-dose, or the last visit if a subject withdrawal early from the study.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
The changes in IL-2 concentrations from baseline.
Measured: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
The changes in IL-4 concentrations from baseline.
Measured: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
The changes in IL-6 concentrations from baseline.
Measured: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
The changes in IL-8 concentrations from baseline.
Measured: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
The changes in IL-10 concentrations from baseline.
Measured: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
The changes in TNF-α concentrations from baseline.
Measured: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
The changes in IFN-γ concentrations from baseline.
Measured: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start30 May 2026 (estimated)
- Primary completion20 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 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
- NCT07443228
- Sponsor's protocol ID
- JL18008
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of JL18008 Injection in HIV-Infected Immunological Non-Responders
- ClinicalTrials.gov ID
- NCT07443228
- Acronym / sponsor ID
- JL18008
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Jecho Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Mar 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.
JL18008 Injection is designed to improve the immune response in cART-treated HIV-infected immunological non-responders (HIV INRs). The study includes 3 trials： Phase Ia: A randomized, single-blind, placebo-controlled, single-dose escalation study to evaluate the tolerability and safety of JL18008 Injection and determine the RED in HIV INRs.
Phase Ib: A randomized, double-blind, placebo-controlled, dose expansion study to evaluate the safety of JL18008 Injection and determine the RP2D in HIV INRs.
Phase II: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JL18008 Injection in HIV INRs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| JL18008 i.m. 1 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
| JL18008 i.m. 2 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
| JL18008 i.m. 4 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
| JL18008 i.m. 8 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
| JL18008 i.m. 16 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
| JL18008 i.m. 30 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
| JL18008 i.m. 50 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
| JL18008 i.m. 70 μg/kg | Experimental | Drug: JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. |
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 between 18 - 65 years old, male or female.
- Body Mass Index (BMI) between 18 - 32 kg/m2, body weight ≥ 50 kg in male and ≥ 45 kg in female.
- On cART for at least 36 months, on stable regimen (no drug or dose changes) for at least 3 months prior to study entry.
- Plasma HIV RNA < 50 copies/mL in last 30 months in minimum two measurements (including the screening measurement) and the two measurements should done within 6 months prior to study entry (note: patients with single blip of detectable viremia during this period will be allowed to participate if the prior and subsequent plasma HIV RNA levels are < 50 copies/mL).
- During 12 months prior to study entry, CD4+ T cell counts > 100 and ≤ 350 cells/µL measured in at least two measurements (including the screening measurement) and the interval between the two measurements should be ≥ 3 months (Note: only one time value of CD4+ T cell count > 350 during this period will be allowed to participate if the previous and subsequent CD4+ T cell count is in the range of > 100 and ≤ 350 cells/µL).
Key exclusion criteria (21 listed)
- Prior treatment with IL-7 or IL-2.
- Allergy to JL18008 Injection components, e.g. HSA.
- Prior treatment with immunomodulatory agents such as thymosin, immunosuppressive drugs, or cytotoxic chemotherapy within 6 months prior to study entry.
- Any history of generalized psoriasis, Crohn's disease, uveitis, systemic lupus erythematosus (SLE), Hashimoto's thyroiditis or other autoimmune diseases.
- Any history of virus, bacteria, parasites or fungal infection and other opportunistic infections requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
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 |
|---|---|---|
| JL18008The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo. | Drug | JL18008 i.m. 1 μg/kg, JL18008 i.m. 16 μg/kg, JL18008 i.m. 2 μg/kg, JL18008 i.m. 30 μg/kg, JL18008 i.m. 4 μg/kg, JL18008 i.m. 50 μg/kg, JL18008 i.m. 70 μg/kg, JL18008 i.m. 8 μg/kg |
Primary outcome
The safety of JL18008
Time frame: 3 months
Number of participants with any death.
The safety of JL18008
Time frame: 3 months
Number of participants with AEs and SAEs.
The safety of JL18008
Time frame: 3 months
Number of participants with discontinuation due to AEs.
16 secondary outcomes
To Evaluate the Pharmacokinetics of JL18008
Time frame: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Time frame: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Time frame: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Time frame: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Time frame: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Time frame: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Pharmacokinetics of JL18008
Time frame: Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Efficacy of Escalating Doses of JL18008
Time frame: The PD sampling time points are: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168(D8), 240(D11), 336(D15), 504(D22), 672(D29), 1320(D56) and 1992(D84) hours of post-dose.
Immunogenicity
Time frame: The samples for ADA assessment will be collected at the following time points: 0.5 hour of pre-dose and 336(D15), 672(D29), 1320(D56) and 1992(D84) hours of post-dose, or the last visit if a subject withdrawal early from the study.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
Time frame: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
Time frame: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
Time frame: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
Time frame: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
Time frame: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
Time frame: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
To Evaluate the Serum Cytokines Concentrations of Escalating Doses of JL18008
Time frame: The samples will be collected at the following time points: 0.5 hour of pre-dose and 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.
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 2 Mar 2026.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JL18008 in people with HIV, run by Jecho Biopharmaceuticals Co., Ltd..
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 21 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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?
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?
The safety of JL18008 (time frame: 3 months). The study lists 3 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 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.