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A Study to Evaluate JL18008 in Healthy Adult Subjects (JL18008)

2026년 6월 4일 업데이트: Jecho Biopharmaceuticals Co., Ltd.

Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study

This study is being conducted in healthy adult volunteers to evaluate the safety and tolerability of a single injection of an investigational drug called JL18008. The study also examines how the body processes the drug and how it affects immune cells. Participants receive one intramuscular injection of either JL18008 at one of six dose levels (1, 5, 10, 20, 40, or 70 μg/kg) or a placebo (an inactive substance). The study is randomized, double-blind, and placebo-controlled, meaning participants and study staff do not know who receives the active drug or placebo. Blood samples are collected over 56 days to measure drug levels, immune cell counts (such as CD4⁺ T cells), and any antibodies that may form against the drug. The goal is to find a safe dose that can be tested in future studies of people with HIV who have low CD4⁺ T cells despite antiviral treatment.

연구 개요

상태

완전한

정황

HIV 감염

개입 / 치료

연구 유형

중재적

등록 (실제)

단계

1단계

연락처 및 위치

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

연구 장소

중국
- - Beijing, 중국
    - 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

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent.
Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests (hematology, urinalysis, serum chemistry, infectious disease screening, coagulation) are normal or have no clinically significant abnormality.
Male or female, age 18 to 55 years inclusive.
Body weight: male ≥50.0 kg, female ≥45.0 kg. Body mass index (BMI) between 18.0 and 26.0 kg/m² inclusive. BMI = weight (kg) / height (m)².
No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease.
No plans for pregnancy within 6 months, and agreement to use effective contraception with their partner from screening until 3 months after the study completion. No donation of sperm or eggs during this period.

Exclusion Criteria:

Any history of allergic disease, or food or drug allergy, that in the investigator's opinion makes the subject unsuitable for inclusion.
Lactating women; women of childbearing potential with menstrual disorders within 90 days before dosing; women of childbearing potential who had unprotected intercourse with a male partner within 28 days before dosing.
Participation in any clinical trial of an investigational drug within 90 days before dosing, or still within the safety washout period of a previous trial on the day of dosing.
Non-physiological blood loss of ≥200 mL (including trauma, blood draw, blood donation) within 60 days before dosing, or plan to donate blood during the study or within 30 days after dosing.
Any major illness considered clinically significant by the investigator within 90 days before dosing.
Major surgery within 60 days before dosing, or any surgery within 28 days before dosing.
Fever or infectious illness within 28 days before dosing.
Use of any medication (including prescription, non-prescription, herbal, or dietary supplements) within 14 days before dosing.
Vaccination within 1 month before dosing, or plan to receive vaccination during the study period.
History or dependence of alcohol or drug abuse, or drug use, or a positive urine drug screen at screening. Alcohol abuse defined as average weekly intake >21 standard alcohol units. One standard unit contains 14 g of alcohol (e.g., 360 mL of 5% beer, 45 mL of 40% spirits, or 120 mL of 12% wine).
Daily smoking of more than 5 cigarettes within 3 months before screening, or unable to refrain from smoking during the study.
Vital signs at screening meeting any of the following: systolic blood pressure <90 mmHg or >140 mmHg; diastolic blood pressure <50 mmHg or >90 mmHg; pulse rate <50 beats/min or >100 beats/min.
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis antibody.
Clinically evident gastrointestinal, hepatic, or renal abnormality that, in the investigator's opinion, may affect drug transport, absorption, distribution, metabolism, or excretion.
Any other condition that, in the investigator's judgment, might affect the study results or interfere with the subject's participation throughout the study, including but not limited to other medical history (e.g., psychiatric disorder), abnormalities in vital signs, physical examination, electrocardiogram, or clinical laboratory tests.

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: 순차적 할당
마스킹: 삼루타

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Arm 1: JL18008 1 μg/kg Single intramuscular injection of JL18008 at 1 μg/kg.	의약품: JL18008 1 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 1 μg/kg.
위약 비교기: Arm 2: Placebo (for 1 μg/kg group) Single intramuscular injection of placebo (JL18008 buffer).	의약품: Placebo (for 1 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 1 μg/kg.
실험적: Arm 3: JL18008 5 μg/kg Single intramuscular injection of JL18008 at 5 μg/kg.	의약품: JL18008 5 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 5 μg/kg.
위약 비교기: Arm 4: Placebo (for 5 μg/kg group) Single intramuscular injection of placebo.	의약품: Placebo (for 5 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 5 μg/kg.
실험적: Arm 5: JL18008 10 μg/kg Single intramuscular injection of JL18008 at 10 μg/kg.	의약품: JL18008 10 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 10 μg/kg.
위약 비교기: Arm 6: Placebo (for 10 μg/kg group) Single intramuscular injection of placebo.	의약품: Placebo (for 10 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 10 μg/kg.
실험적: Arm 7: JL18008 20 μg/kg Single intramuscular injection of JL18008 at 20 μg/kg.	의약품: JL18008 20 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 20 μg/kg.
위약 비교기: Arm 8: Placebo (for 20 μg/kg group) Single intramuscular injection of placebo.	의약품: Placebo (for 20 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 20 μg/kg.
실험적: Arm 9: JL18008 40 μg/kg Single intramuscular injection of JL18008 at 40 μg/kg.	의약품: JL18008 40 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 40 μg/kg.
위약 비교기: Arm 10: Placebo (for 40 μg/kg group) Single intramuscular injection of placebo.	의약품: Placebo (for 40 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 40 μg/kg.
실험적: Arm 11: JL18008 70 μg/kg Single intramuscular injection of JL18008 at 70 μg/kg.	의약품: JL18008 70 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 70 μg/kg.
위약 비교기: Arm 12: Placebo (for 70 μg/kg group) Single intramuscular injection of placebo.	의약품: Placebo (for 70 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 70 μg/kg.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0 기간: Up to 56 days	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). AEs graded according to NCI CTCAE version 5.0. Assessed from Day 1 through Day 56.	Up to 56 days

2차 결과 측정

결과 측정	측정값 설명	기간
Change from Baseline in White Blood Cell Count (WBC) 기간: Up to 56 days	Change from baseline in white blood cell count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Neutrophil Count (NEUT) 기간: Up to 56 days	Change from baseline in neutrophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Eosinophil Count (EOS) 기간: Up to 56 days	Change from baseline in eosinophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Basophil Count (BASO) 기간: Up to 56 days	Change from baseline in basophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Lymphocyte Count (LYMPH) 기간: Up to 56 days	Change from baseline in lymphocyte count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Red Blood Cell Count (RBC) 기간: Up to 56 days	Change from baseline in red blood cell count. Measured in 10¹²/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Hemoglobin (HGB) 기간: Up to 56 days	Change from baseline in hemoglobin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Platelet Count (PLT) 기간: Up to 56 days	Change from baseline in platelet count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Hematocrit (HCT) 기간: Up to 56 days	Change from baseline in hematocrit. Measured as a percentage (%). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Bilirubin (TBIL) 기간: Up to 56 days	Change from baseline in total bilirubin. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Protein (TP) 기간: Up to 56 days	Change from baseline in total protein. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Albumin (ALB) 기간: Up to 56 days	Change from baseline in albumin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Alanine Aminotransferase (ALT) 기간: Up to 56 days	Change from Baseline in Alanine Aminotransferase (ALT)	Up to 56 days
Change from Baseline in Aspartate Aminotransferase (AST) 기간: Up to 56 days	Change from baseline in aspartate aminotransferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Gamma-Glutamyl Transferase (γ-GT) 기간: Up to 56 days	Change from baseline in gamma-glutamyl transferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Creatinine (Cr) 기간: Up to 56 days	Change from baseline in creatinine. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Cholesterol (TCHO) 기간: Up to 56 days	Change from baseline in total cholesterol. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Triglycerides (TG) 기간: Up to 56 days	Change from baseline in triglycerides. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Blood Urea Nitrogen (BUN)/Urea 기간: Up to 56 days	Change from baseline in blood urea nitrogen. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Alkaline Phosphatase (ALP) 기간: Up to 56 days	Change from baseline in alkaline phosphatase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Blood Glucose (GLU) 기간: Up to 56 days	Change from baseline in blood glucose. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Phosphorus (Pi) 기간: Up to 56 days	Change from baseline in serum phosphorus. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Sodium (Na⁺) 기간: Up to 56 days	Change from baseline in serum sodium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Potassium (K⁺) 기간: Up to 56 days	Change from baseline in serum potassium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Calcium (Ca²⁺) 기간: Up to 56 days	Change from baseline in serum calcium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Magnesium (Mg²⁺) 기간: Up to 56 days	Change from baseline in serum magnesium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Chloride (Cl-) 기간: Up to 56 days	Change from baseline in serum chloride. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in International Normalized Ratio (INR) 기간: Up to 56 days	Change from baseline in international normalized ratio. Unitless ratio. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Activated Partial Thromboplastin Time (APTT) 기간: Up to 56 days	Change from Baseline in Activated Partial Thromboplastin Time (APTT)	Up to 56 days
Change from Baseline in Prothrombin Time (PT) 기간: Up to 56 days	Change from baseline in prothrombin time. Measured in seconds. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Fibrinogen (FIB) 기간: Up to 56 days	Change from baseline in fibrinogen. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in ECG Parameter: QTcF Interval 기간: Up to 56 days	Change from baseline in the QT interval corrected for heart rate using Fridericia's formula (QTcF). Measured in milliseconds (ms). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Systolic Blood Pressure (SBP) 기간: Up to 56 days	Change from baseline in systolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Change from Baseline in Diastolic Blood Pressure (DBP) 기간: Up to 56 days	Change from baseline in diastolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Change from Baseline in Pulse Rate 기간: Up to 56 days	Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Peak Plasma Concentration (Cmax) - Single Dose 기간: Up to 672 hours after first dose	Maximum observed plasma concentration following single intramuscular injection. Measured in pg/mL. Assessed at pre-dose and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.	Up to 672 hours after first dose
Time to Reach Peak Plasma Concentration (Tmax) - Single Dose 기간: Up to 672 hours after first dose	Time to reach maximum observed plasma concentration. Measured in hours (h). Same time points as Cmax.	Up to 672 hours after first dose
Elimination Half-Life (t½) - Single Dose 기간: Up to 672 hours after first dose	Elimination half-life calculated as ln(2)/λz. Measured in hours (h).	Up to 672 hours after first dose
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC₀-ₗₐₛₜ) - Single Dose 기간: Up to 672 hours after first dose	AUC using linear trapezoidal rule. Measured in h·pg/mL.	Up to 672 hours after first dose
Area Under the Curve from Time 0 to Infinity (AUC₀-∞) - Single Dose 기간: Up to 672 hours after first dose	Extrapolated AUC. Measured in h·pg/mL.	Up to 672 hours after first dose
Area Under the Curve from Time 0 to 168 Hours (AUC₀-₁₆₈ₕ) - Single Dose 기간: Up to 168 hours after first dose	AUC from 0 to 168 hours post-dose. Measured in h·pg/mL.	Up to 168 hours after first dose
Apparent Clearance (CL/F) - Single Dose 기간: Up to 672 hours after first dose	Dose divided by AUC₀-∞. Measured in L/h.	Up to 672 hours after first dose
Apparent Volume of Distribution (Vz/F) - Single Dose 기간: Up to 672 hours after first dose	Dose divided by (λz × AUC₀-∞). Measured in L.	Up to 672 hours after first dose
Change from Baseline in CD4⁺ T Cell Count 기간: Up to 56 days	Change from baseline in absolute CD4⁺ T cell count. Measured in cells/μL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1320 hours post-dose.	Up to 56 days
Change from Baseline in CD8⁺ T Cell Count 기간: Up to 56 days	Change from baseline in absolute CD8⁺ T cell count. Measured in cells/μL. Same time points as CD4⁺.	Up to 56 days
Change from Baseline in CD4/CD8 T Cell Ratio 기간: Up to 56 days	Change from baseline in the ratio of CD4⁺ to CD8⁺ T cells. Unitless ratio. Same time points as CD4⁺.	Up to 56 days
Change from Baseline in Serum Interleukin-2 (IL-2) Level 기간: Up to 672 hours (28 days)	Change from baseline in serum IL-2 level. Measured in pg/mL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-4 (IL-4) Level 기간: Up to 672 hours (28 days)	Change from baseline in serum IL-4 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-6 (IL-6) Level 기간: Up to 672 hours (28 days)	Change from baseline in serum IL-6 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-8 (IL-8) Level 기간: Up to 672 hours (28 days)	Change from baseline in serum IL-8 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-10 (IL-10) Level 기간: Up to 672 hours (28 days)	Change from baseline in serum IL-10 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Level 기간: Up to 672 hours (28 days)	Change from baseline in serum TNF-α level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interferon-gamma (IFN-γ) Level 기간: Up to 672 hours (28 days)	Change from baseline in serum IFN-γ level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Number of Participants with Anti-Drug Antibodies (ADA) 기간: Up to 56 days	Incidence of anti-drug antibodies (ADA) against JL18008. For ADA-positive participants, titers and neutralizing antibodies (Nab) will be assessed. Assessed at baseline and at 168, 336, 504, 672, 1320 hours post-dose.	Up to 56 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Jecho Biopharmaceuticals Co., Ltd.

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 (실제)

2024년 6월 13일

기본 완료 (실제)

2025년 8월 5일

연구 완료 (실제)

2025년 8월 5일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 4일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

JL18008-HV/HIV INR-101（Ia）
CTR20241578 (레지스트리 식별자: Drug Clinical Trial Registration and Information Disclosure Platform, Center for Drug Evaluation, NMPA, China)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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

Duke University
Gilead Sciences

모병

지속성 주사제 PrEP를 사용하여 남부 라틴계 TGW 및 GBM의 PrEP 활용 및 유지 강화 (INCLUSION)

HIV 예방 | HIV 사전 노출 예방 | HIV 예방 프로그램 | HIV 예방 및 관리 | HIV 사전 노출 예방 사용

미국
Institute of HIV Research and Innovation Foundation...
National Institutes of Health (NIH)

모병

트랜스젠더 여성 대상 HIV 예방 및 낙인 극복을 위한 모바일 헬스 중재 평가 (EMPOW.HER)

HIV 예방 | PrEP 준수 | HIV 관련 낙인

태국
Johns Hopkins University
National Institute of Mental Health (NIMH)

모병

안전한 공간 4 성 건강 (SS4SH)

HIV 예방 | HIV 위험 행동 | HIV 상담 및 테스트

미국
Massachusetts General Hospital
National Institute of Mental Health (NIMH)

모병

HIV 미지 감염 산후 여성의 파트너를위한 HIV 자체 테스트

실행할 수 있음 | HIV 예방 | PrEP 흡수 | 수용 가능성 | HIV 자가 테스트 | HIV 음성 산후 여성의 남성 파트너

남아프리카
State University of New York at Buffalo
Yale University Center for Interdisciplinary Research on AIDS

아직 모집하지 않음

Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants. (MiST-Pathways)

HIV 예방 | HIV 테스트 | 성 및 생식 건강

미국
Hospital Clinic of Barcelona

완전한

HIV 감염 환자에서 Raltegravir 및 Darunavir/Ritonavir의 이중 요법. (RALDAR)

인테그라제 억제제, HIV; HIV 프로테아제 억제

스페인
Instituto Mexicano del Seguro Social

모병

INSTI와 비교하여 DOR/3TC/TDF를 사용한 PWH의 체중 및 BMI 변화 (TLATOANI)

체중 감량 | 에이즈 | HIV-1 감염 | 체중 변화 | HIV 관련 체중 감소 | 인테그라제 억제제, HIV; HIV 프로테아제 억제

멕시코
University of California, Los Angeles

모병

로스앤젤레스 카운티에서의 모바일 차량 기반 렌아카파비르 PrEP 배송 (MOVE-LA)

HIV 예방

미국
Thomas Aagaard Rasmussen
Aarhus University Hospital; The Alfred; Germans Trias i Pujol Hospital; Walter and Eliza Hall...

모병

ART 시작 시점에 항세포사멸 인자인 BCL-2를 억제하여 HIV 감염 세포의 세포사멸을 촉진하고 HIV 저장소의 형성을 제한하기 위한 연구자 주도 무작위 대조 개방형 임상시험 (INITIATE 연구) (INITIATE)

HIV-1

덴마크, 스페인
University of Minnesota

빼는

N-803은 HIV에 대한 플러스 또는 마이너스 행크 세포를 광범위하게 중화시키는 항체와 결합

HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염

미국

JL18008 1 μg/kg에 대한 임상 시험

ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.

완전한

RAB001(LLP2A-Ale) 건강한 피험자 대상 (LLP2A-Ale)

대퇴골두 골괴사증

중국
Tanta University

완전한

패혈성 쇼크 환자에서 조직 관류 예측에 대한 말초 관류 지수의 정확도에 미치는 다양한 노르에피네프린 용량의 영향

패혈성 쇼크 | 말초 관류 지수

이집트
Cairo University

모병

슬관절 정형외과 수술을 받는 환자에서 부피바카인과 함께 척수강내 투여하는 덱스메데토미딘

부피바카인 | 경막내 덱스메데토미딘 | 무릎 정형외과 수술

이집트
Kasr El Aini Hospital

완전한

노인의 척추 유발 저혈압에 대한 예방에 대한 두 가지 다른 노르 에피네프린 주입 속도 비교

고령자(65세 이상) | 척추 마취 후 저혈압 | 척추 마취

이집트
Supernus Pharmaceuticals, Inc.

완전한

산후 우울증이 적당한 참가자에서 SAGE-547의 안전성과 효능을 평가하는 연구 (547-PPD-202C)

산후 우울증

미국
Huahui Health

완전한

진행성 고형 종양 환자에서 HH-101의 안전성, 내약성, 약동학 및 예비 효능을 평가하는 제1상 임상 시험

고형종양

중국
Shanghai Henlius Biotech

아직 모집하지 않음

진행성 췌장암 환자를 대상으로 HLX43을 평가하기 위한 제2상 임상시험

췌관 선암(PDAC)
Healthgen Biotechnology Corp.

모병

건강한 지원자의 OsrhAAT 또는 위약 연구

선천성 AATD에 이차적인 폐기종

미국
Shanghai Huicun Medical Technology Co., Ltd.

초대로 등록

HCL001 세포 주사제를 이용한 비보상성 간경변 치료: 1상/2상 임상시험 (HCL001)

보상되지 않은 간경변

중국
The First Affiliated Hospital of Xiamen University

모집하지 않고 적극적으로

초음파 유도 간 종양 열 절제 동안 에스 케타민의 효과적인 용량 및 안전성

간암 | 간 신생물

중국

A Study to Evaluate JL18008 in Healthy Adult Subjects (JL18008)

Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study

연구 개요

상태

정황

개입 / 치료

연구 유형

등록 (실제)

단계

연락처 및 위치

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (실제)

연구 완료 (실제)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

HIV 감염에 대한 임상 시험

JL18008 1 μg/kg에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Vietnam

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치