NCT07735104 The First in Human Study of QLS2319 in Healthy Subjects and Cancer Cachexia
| NCT ID | NCT07735104 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Cancer Cachexia |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2026-09-16 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 88 participants in total. It began in 2026-09-16 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07735104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Cancer Cachexia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07735104 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07735104 currently recruiting?
Yes, NCT07735104 is actively recruiting participants. Contact the research team at zhangli@sysucc.org.cn for enrollment information.
Where is the NCT07735104 trial being conducted?
This trial is being conducted at Hefei, China, Guangzhou, China.
Who is sponsoring the NCT07735104 clinical trial?
NCT07735104 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 88 participants.
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