The First in Human Study of QLS2319 in Healthy Subjects and Cancer Cachexia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Subjects aged ≥ 18 years at screening;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
QLS2319
DrugQLS2319 will be administered via subcutaneous injection
Placebo
Drugplacebo will be administered via subcutaneous injection
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: QLS2319Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Up to Day 992
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)
Time frame
Up to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov