Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS2319, Placebo.
- Who it may be relevant to
- Registry conditions: Cancer Cachexia Syndrome, Cancer Cachexia. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
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.
Interventions
- Drug QLS2319
QLS2319 will be administered via subcutaneous injection - Drug Placebo
placebo will be administered via subcutaneous injection
Primary outcome measures
- Phase Ia：Safety and tolerability after a single subcutaneous injection of QLS2319/placebo [Time frame: Up to Day 99]
- Phase Ib：Safety and tolerability after multiple subcutaneous injections of QLS2319 [Time frame: Up to 12 weeks]
Eligibility criteria
Inclusion criteria
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; -
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun-Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07735104 · QLS2319-101