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

NCT07735104 | Not Yet Recruiting Phase 1

• 1 other identifier: QLS2319-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Cachexia Syndrome; Cancer Cachexia

Keywords

Cancer Cachexia; QLS2319; Cancer Cachexia Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

QLS2319

EXPERIMENTAL

QLS2319 s.c.

Drug: QLS2319

placebo

PLACEBO COMPARATOR

placebo s.c.

Drug: Placebo

Interventions

QLS2319 DRUG

QLS2319 will be administered via subcutaneous injection

QLS2319

Placebo DRUG

placebo will be administered via subcutaneous injection

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun-Yat-sen University Cancer Center

Guangzhou, China

Location

Central Study Contacts

Li Zhang

CONTACT

020-87343458; zhangli@sysucc.org.cn

Yan Huang

CONTACT

020-87343366; huangyan@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

CN (1)