Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (54)

Change from Baseline in White Blood Cell Count (WBC)
Up to 56 days
Change from Baseline in Neutrophil Count (NEUT)
Up to 56 days
Change from Baseline in Eosinophil Count (EOS)
Up to 56 days
Change from Baseline in Basophil Count (BASO)
Up to 56 days
Change from Baseline in Lymphocyte Count (LYMPH)
Up to 56 days
+49 more secondary outcomes

Study Arms (12)

Arm 1: JL18008 1 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 1 μg/kg.

Drug: JL18008 1 μg/kg

Arm 2: Placebo (for 1 μg/kg group)

PLACEBO COMPARATOR

Single intramuscular injection of placebo (JL18008 buffer).

Drug: Placebo (for 1 μg/kg Group)

Arm 3: JL18008 5 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 5 μg/kg.

Drug: JL18008 5 μg/kg

Interventions

JL18008 1 μg/kgDrug

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 1 μg/kg.

Arm 1: JL18008 1 μg/kg

JL18008 5 μg/kgDrug

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Jecho Biopharmaceuticals Co., Ltd.
Industrylead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

MeSH Terms

Conditions

HIV Infections

Interventions

WW Domain-Containing OxidoreductasePopulation Groups

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital Diseases

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 5, 2026

Study Start

June 13, 2024

Actual (reported)

You may not qualify if:

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.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (54)

Study Arms (12)

Arm 1: JL18008 1 μg/kg

Arm 2: Placebo (for 1 μg/kg group)

Arm 3: JL18008 5 μg/kg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Arm 4: Placebo (for 5 μg/kg group)

Arm 5: JL18008 10 μg/kg

Arm 6: Placebo (for 10 μg/kg group)

Arm 7: JL18008 20 μg/kg

Arm 8: Placebo (for 20 μg/kg group)

Arm 9: JL18008 40 μg/kg

Arm 10: Placebo (for 40 μg/kg group)

Arm 11: JL18008 70 μg/kg

Arm 12: Placebo (for 70 μg/kg group)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations