Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
Starting soon · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Cancer Cachexia Syndrome, Cancer Cachexia
In brief
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
Key facts
- Study ID
- NCT07735104
- Run by
- Qilu Pharmaceutical Co., Ltd.
- People needed
- 88
- Starts
- 2026-09-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ia phase:
- Male and female subjects aged 18-55 years (inclusive), at the time of signing the ICF.;
- 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);
- 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:
- Subjects aged ≥ 18 years at screening;
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
- ECOG performance status score of 0, 1;
- Cancer cachexia documented in medical records; -
You may not qualify if…
- Ia phase:
- 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.
- History of HIV infection, syphilis, hepatitis B, or hepatitis C;
- History of recurrent infections or active infections；
- Subjects who, in the judgment of the investigator, are not suitable for participation in the study.
- Ib phase:
- Current active reversible causes of decreased food intake
- Cachexia caused by other reasons
- Receiving tube feedings or parenteral nutrition within 28 days prior to the first administration of the investigational product
- 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.
- Subjects with known allergy to QLS2319 or any of its components, or with a history of severe allergic reactions or uncontrolled allergic asthma.
Where it is running
- Sun-Yat-sen University Cancer Center — Guangzhou, China
Full record on ClinicalTrials.gov
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