A Study to Evaluate Effects of KN056 in Healthy Participants

Status Completed

Clinical Trial Summary

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 KN056 in healthy participants.

Clinical Trial Description

KN056 is a biological innovative drug developed as a treatment for type 2 diabetes. It is a recombinant human Fc-fused GLP-1 variant protein. GLP-1 can activate the intracellular pathway to cause the elevation of cAMP, thereby promoting insulin secretion and inhibiting glucagon secretion. The study will involve a single ascending (increasing) dose (SAD) study and will enroll up to 46 healthy participants across 7 dosing groups. Cohort 1 - 0.1mg (2 participants, both receiving KN056 separated by at least 1 day) Cohort 2 - 0.3mg (4 participants, dosed as 2 +2, separated by a safety observation of at least 3 days) Cohort 3 - 1.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 4 - 3.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 5 - 6.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 6 - 12.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 7 - 18.0mg (6 participants receiving KN056 + 2 receiving placebo) In Cohort 3 to 6; the first 2 subjects will be as sentries, and will be injected with KN056 or placebo randomly: at least 3 days after 2 sentries' administration, the remaining 6 participants will be randomized to receive KN056 or placebo in a 5:1 ratio. Additional dose group: the number and randomization of Cohort 7 participants are identical to those in Cohort 3 to Cohort 6. The dose will be given as a subcutaneous (SC) injection into the abdomen. ;

Study Design

Related Conditions & MeSH terms

Type 2 Diabetes

Clinical Trial Details

NCT number	NCT05385575
Study type	Interventional
Source	Suzhou Alphamab Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	August 9, 2022
Completion date	February 29, 2024

View Details

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