Randomized, Single-blind, Placebo-controlled Exploratory Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety, Tolerability of KN060 in Patients With Essential Hypertension

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• men or women ≥ 18 years of age and ≤ 65 years of age;

• patients with essential hypertension who are not receiving drug therapy or are receiving stable monotherapy (stable therapy: no change in antihypertensive drugs and doses within 30 days before screening);

• AOBP mean sitting SBP ≥ 140 and \< 180 mmHg (at least 5 minutes rest before measurement, 3 measurements averaged over at least 1 minute apart) and mean SBP ≥ 130 and ≤ 160 mmHg at 24 hours ABPM;

Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Yanrong Dong, Master
yanrongdong@alphamab.com
+86 18914005458
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 60
Treatments
Placebo_comparator: 0.9% Sodium Chloride Injection
0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks
Experimental: KN060
The dose was calculated based on the fasting body weight of the subject D1, and the corresponding volume of KN060 was drawn and added to 0.9% sodium chloride injection to prepare a 100 ml solution by intravenous drip every two weeks
Related Therapeutic Areas
Sponsors
Leads: Suzhou Alphamab Co., Ltd.

This content was sourced from clinicaltrials.gov