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Clinical Trials in China / NCT07735104
Starting soon Phase 1/2

Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia

NCT07735104 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 1/2
Started
2026-09-01
Last updated
2026-07-29

Condition(s) studied

Cancer Cachexia SyndromeCancer Cachexia

Investigational drug(s) / intervention(s)

QLS2319Placebo

QLS2319: QLS2319 will be administered via subcutaneous injection

Placebo: placebo will be administered via subcutaneous injection

Study summary

Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: Ia phase: 1. Male and female subjects aged 18-55 years (inclusive), at the time of signing the ICF.; 2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2 (m) 2) of 18.5-26 kg/m2 (inclusive); 3. Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose; Ib phase: 1. Subjects aged ≥ 18 years at screening; 2. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures; 3. ECOG performance status score of 0, 1; 4. Cancer cachexia documented in medical records; - Exclusion Criteria: Ia phase: 1. Subjects with clinically significant abnormal laboratory findings, or with clinically significant diseases or conditions, who are considered by the investigator to be ineligible for enrollment in this study. 2. History of HIV infection, syphilis, hepatitis B, or hepatitis C; 3. History of recurrent infections or active infections; 4. Subjects who, in the judgment of the investigator, are not suitable for participation in the study. Ib phase: 1. Current active reversible causes of decreased food intake 2. Cachexia caused by other reasons 3. Receiving tube feedings or parenteral nutrition within 28 days prior to the first administration of the investigational product 4. Presence of concomitant conditions, other than neoplastic cachexia, which are deemed by the investigator to cause difficulty in oral intake or malabsorption of ingested food. 5. Subjects with known allergy to QLS2319 or any of its components, or with a history of severe allergic reactions or uncontrolled allergic asthma.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun-Yat-sen University Cancer Center Guangzhou China

More Qilu Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07735104 on ClinicalTrials.gov ↗ ← All trials in China