Clinical trials

5

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Safety of KN057 Prophylaxis in Patients With Haemophilia A or B

The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057. The participants in Part PK will be randomly assigned to Old process Group or New process Group in a 1:1 ratio. The participants in Old process Group will receive old process KN057 prophylaxis for the first 26 weeks and new process KN057 prophylaxis for the following 26 weeks. The participants in New process Group will receive new process KN057 prophylaxis for both the first 26 weeks and the last 26 weeks. The participants in Part non-PK will be non-randomized and treated with new process KN057 for 52 weeks prophylaxis after enrollment. Priority screening and enrollment of participants who have participated in the KN057-A-301 or KN057-A-302 study.

Participants needed: 70
Trial details
Phase: Phase 3Age: 12-65Biological sex: MaleType: InterventionalSponsor: Suzhou Alphamab Co., Ltd.Updated: Apr 22, 2026Locations: 1
Eligibility criteria

Male, 12 to 65 years old at the time of signing informed consent, body weight ≥3... [+2]

Have serious or poorly controlled chronic diseases or obvious systemic diseases. [+7]

Status: Recruiting

To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients

The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis. The secondary objectives to evaluate the pharmacokinetic and pharmacodynamic properties of multiple doses of KN060; to evaluate the immunogenicity of KN060; and to explore the efficacy of KN060 in preventing dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis in patients with end-stage renal disease undergoing regular hemodialysis. The main questions it aims to answer are: * Whether KN060 is safe for ESRD dialysis patients * Pharmacokinetic characteristics of KN060 in ESRD dialysis patients * Whether KN060 can effectively prevent dialyzer and extracorporeal circuit thrombosis Researchers will evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics profile, dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis of KN060 in ESRD dialysis patients Subjects will : * Eligible subjects will receive KN060 2.5 mg/kg every two weeks for a total of 6 doses. * Assessed for the number, incidence, and severity of AEs, dialyzer thrombus, extracorporeal circuit thrombus, arteriovenous fistula thrombus, and time to hemostasis at the arteriovenous fistula puncture site.

Participants needed: 12
Trial details
Phase: Phase 1, Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Suzhou Alphamab Co., Ltd.Updated: Oct 1, 2025Locations: 1
Eligibility criteria

Male or female subjects aged between 18 and 80 years (inclusive); [+6]

A history of malignant tumor; [+3]

Status: Recruiting

To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension

The primary objective of this study is to compare the change from baseline in systolic blood pressure between KN060 and placebo in patients with essential hypertension over 12 weeks; the secondary objectives are to assess the safety and tolerability of KN060 and to assess the pharmacokinetic and pharmacodynamic properties and immunogenicity of KN060 in patients with essential hypertension. The main questions it aims to answer are: * To verify the efficacy of KN060 in patients with essential hypertension * Safety of KN060 in Subjects Treated for Essential Hypertension Researchers will compare KN060 to placebo (0.9% sodium chloride 100ml) to assess the antihypertensive effect of KN060. Subjects will : * Receive KN060 or placebo by intravenous drip every two weeks for 6 doses. * AOBP, 24hABPM, HBPM,and safety were monitored and recorded.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Suzhou Alphamab Co., Ltd.Updated: Sep 25, 2025Locations: 1
Eligibility criteria

men or women ≥ 18 years of age and ≤ 65 years of age; [+2]

secondary hypertension: kidney disease, endocrine disease, cardiovascular diseas... [+10]

Status: Recruiting

A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight

This is a Phase 1, First-in-human, double-blinded, placebo-controlled study which aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the immunogenicity of KN069 in Chinese male participants with Obesity or Overweight.

Participants needed: 36
Trial details
Phase: Phase 1Age: 18-55Biological sex: MaleType: InterventionalSponsor: Suzhou Alphamab Co., Ltd.Updated: Sep 17, 2025Locations: 1
Eligibility criteria

Male, 18-55 years old (including threshold); [+3]

Those who have a history of chronic diseases or are currently suffering from obv... [+21]

Status: Not yet recruiting

KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors

The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity \<1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%). Participants will be administered subcutaneously with KN057 once a week for 20 weeks. KN057 works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly subcutaneous administration provides better convenience and compliance.

Participants needed: 24
Trial details
Phase: Phase 2Age: 18-70Biological sex: MaleType: InterventionalSponsor: Suzhou Alphamab Co., Ltd.Updated: Dec 24, 2024
Eligibility criteria

Male, 18-70 years old (including thresholds), body weight ≥40 kg and BMI <30 kg/... [+4]

Those with serious or poorly controlled chronic diseases or obvious systemic dis... [+19]