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

Trial statusNot yet recruiting
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

Qualifiers

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

Treatments tested in this trial

  • QLS2319
  • Placebo

Treatment groups

88 Participants
are divided into 2 treatment groups

Sponsors and collaborators