Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLongbio Pharma

About this trial

This is a multicenter, open-label, proof-of-concept, phase Ⅱ adaptive basket clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of LP-005 Injection as add-on therapy to standard treatment in patients with complement-mediated renal diseases.

Eligibility criteria

Qualifiers

Males or females aged 18 to 65 years at screening.

Body weight of ≥ 40 kg and a body mass index (BMI) within the range of 15 to 35 kg/m² (inclusive).

Patients with complement-mediated renal disease.

Females and males of childbearing potential (including the participants' partners) must agree to use effective contraceptive measures during the trial and for 3 months after the trial ends.

Disqualifiers

Pregnant or lactating female.

History of meningococcal infection.

Active, uncontrolled acute, chronic, or recurrent infection within 4 weeks prior to screening.

Other severe, poorly controlled comorbidities within 3 months prior to screening.

Trial design

Treatments tested in this trial

  • LP-005 Injection

Treatment groups

46 Participants
are divided into 1 treatment group

Sponsors and collaborators