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A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders (JL18008)

2026년 5월 6일 업데이트: Jecho Biopharmaceuticals Co., Ltd.

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.

연구 개요

연구 유형

중재적

등록 (추정된)

30

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Prof. Taisheng Li
  • 전화번호: +86-10-69156114
  • 이메일: litsh@263.net

연구 장소

    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100730
        • Peking Union Medical College Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Age 18 to 65 years (inclusive), male or female.
  2. 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.
  3. 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).

  4. 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).
  5. 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.
  6. Able to understand and provide written informed consent, and willing to comply with all protocol-specified visits and procedures.

Exclusion Criteria:

  1. Known allergy to the study drug or any of its excipients.
  2. Receipt of immunosuppressants, immunomodulators, or systemic cytotoxic therapy within 3 months before screening.
  3. Receipt of hormone therapy within 1 month before screening, except for daily doses ≤10 mg prednisone or equivalent.
  4. History of severe autoimmune disease requiring systemic treatment or hospitalization, or any active autoimmune disease requiring treatment (including multiple sclerosis).
  5. History of systemic infection (viral, bacterial, parasitic, or fungal) requiring systemic treatment and/or hospitalization, or other opportunistic infection, within 30 days before screening.
  6. Active tuberculosis lesion within 30 days before screening.
  7. Blood disorders associated with hypersplenism (e.g., thalassemia, hereditary spherocytosis, Gaucher's disease, autoimmune hemolytic anemia) or history of splenectomy.
  8. Chronic diarrhea.
  9. Severe cardiovascular disease within 6 months before screening, including myocardial infarction, unstable angina, congestive heart failure (NYHA class ≥II), or arrhythmia requiring medication.
  10. 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.
  11. Positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCV-Ab) with detectable HCV-RNA, or active syphilis.
  12. 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.
  13. Diagnosis of cancer within the screening period.
  14. Severe neurological or psychiatric disease, or history of seizures.
  15. 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.
  16. Participation in another clinical trial with receipt of investigational drug within 3 months before screening.
  17. Vaccination within 6 weeks before screening, or plan to receive any vaccination within 1 year after enrollment.
  18. Pregnancy, positive pregnancy test, or breastfeeding.
  19. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: JL18008 20 μg/kg
Participants receive JL18008 20 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.
Participants receive JL18008 20 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
위약 비교기: 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.
Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
실험적: JL18008 40 μg/kg
Participants receive JL18008 40 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.
Participants receive JL18008 40 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
위약 비교기: 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.
Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
실험적: JL18008 70 μg/kg
Participants receive JL18008 70 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.
Participants receive JL18008 70 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).
위약 비교기: 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.
Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by DAIDS v2.1
기간: 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.
Up to 24 weeks
Change from Baseline in Vital Signs: Pulse Rate (bpm)
기간: 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.
Up to 24 weeks
Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (mmHg)
기간: 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.
Up to 24 weeks
Change from Baseline in Hematology Parameters
기간: 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.
Up to 24 weeks
Change from Baseline in Serum Chemistry Parameters
기간: 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.
Up to 24 weeks
Change from Baseline in Coagulation Parameters
기간: 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.
Up to 24 weeks
Change from Baseline in ECG Parameter: QTcF Interval
기간: 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.
Up to 24 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of Participants with CD4⁺ T Cell Count Increase ≥100 cells/μL from Baseline
기간: Up to 24 weeks
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.
Up to 24 weeks
Proportion of Participants Achieving CD4⁺ T Cell Count ≥500 cells/μL
기간: Up to 24 weeks
Proportion of participants with CD4⁺ T cell count reaching 500 cells/μL or higher. Assessed at Weeks 4, 8, 12, 16, 20, and 24.
Up to 24 weeks
Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 12 Weeks
기간: Baseline through Week 12
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.
Baseline through Week 12
Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 12 Weeks
기간: Baseline through Week 12
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.
Baseline through Week 12
Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 24 Weeks
기간: Baseline through Week 24
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.
Baseline through Week 24
Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 24 Weeks
기간: Baseline through Week 24
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.
Baseline through Week 24
Change from Baseline in CD4/CD8 T Cell Ratio
기간: Up to 24 weeks
Change from baseline in the ratio of CD4⁺ to CD8⁺ T cells. Assessed at baseline and Weeks 4, 8, 12, 16, 20, and 24.
Up to 24 weeks
Proportion of Participants with HIV-1 RNA <50 copies/mL
기간: Up to 24 weeks
Proportion of participants maintaining HIV-1 RNA below 50 copies/mL. Assessed at Weeks 4, 8, 12, 16, 20, and 24.
Up to 24 weeks
Number of Participants with Clinical Events
기간: Up to 24 weeks
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.
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)
기간: Up to 24 weeks
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.
Up to 24 weeks
Change from Baseline in Lymphocyte Subset Counts (cells/μL)
기간: Up to 24 weeks
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.
Up to 24 weeks
Peak Plasma Concentration (Cmax) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Time to Reach Peak Plasma Concentration (Tmax) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Elimination Half-Life (t½) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Area Under the Curve from Time 0 to Infinity (AUC0-inf) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Area Under the Curve from Time 0 to 168 Hours (AUC0-168h) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Apparent Clearance (CL/F) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Apparent Volume of Distribution (Vz/F) - Single Dose
기간: Up to 168 hours after first 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.
Up to 168 hours after first dose
Steady-State Peak Plasma Concentration (Cmax, ss)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Steady-State Time to Reach Peak Plasma Concentration (Tmax, ss)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Steady-State Minimum Plasma Concentration (Cmin, ss)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Steady-State Average Plasma Concentration (Cavg, ss)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Area Under the Curve Over Dosing Interval (AUC0-tau) - Steady State
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Steady-State Area Under the Curve from Time 0 to Infinity (AUC0-inf, ss)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Steady-State Apparent Clearance (CLss/F)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Steady-State Apparent Volume of Distribution (Vss/F)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Steady-State Elimination Half-Life (t½, ss)
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Degree of Fluctuation (DF) - Steady State
기간: Up to 168 hours after the fourth dose (Week 4)
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.
Up to 168 hours after the fourth dose (Week 4)
Accumulation Ratio for Cmax (RacCmax)
기간: From first dose to steady state (Week 4)
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).
From first dose to steady state (Week 4)
Accumulation Ratio for AUC (RacAUC0-tau)
기간: From first dose to steady state (Week 4)
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).
From first dose to steady state (Week 4)
Number of Participants with Anti-Drug Antibodies (ADA)
기간: Up to 24 weeks
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.
Up to 24 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 4월 30일

기본 완료 (추정된)

2027년 7월 21일

연구 완료 (추정된)

2027년 9월 28일

연구 등록 날짜

최초 제출

2026년 4월 21일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

HIV 감염에 대한 임상 시험

JL18008 20 μg/kg에 대한 임상 시험

구독하다