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

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS2319 for Injection/Placebo Following Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Subjects With Cancer Cachexia.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Cachexia; Cancer Cachexia Syndrome
• Intervention / Treatment: Drug: QLS2319; Drug: Placebo

Detailed Description

This study is a first-in-human, dose-escalation trial in healthy adult participants and cancer cachexia to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of QLS2319.

The target population of dose escalation part is healthy adult participants, and the dose expansion part will enroll patients with cancer cachexia.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Li Zhang; Phone Number: 020-87343458; Email: zhangli@sysucc.org.cn
• Study Contact Backup: Name: Yan Huang; Phone Number: 020-87343366; Email: huangyan@sysucc.org.cn

Study Locations

• China
  • Guangzhou, China
    • Sun-Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS2319; QLS2319 s.c.	Drug: QLS2319; QLS2319 will be administered via subcutaneous injection
Placebo Comparator: placebo; placebo s.c.	Drug: Placebo; placebo will be administered via subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase Ia：Safety and tolerability after a single subcutaneous injection of QLS2319/placebo	Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)	Up to Day 99
Phase Ib：Safety and tolerability after multiple subcutaneous injections of QLS2319	Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 26, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 26, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cancer Cachexia; QLS2319; Cancer Cachexia Syndrome
• Other Study ID Numbers: QLS2319-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No