NCT05385575

A Study to Evaluate Effects of KN056 in Healthy Participants

A Randomized, Double-blind and Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN056 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Suzhou Alphamab Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	KN056 (0.1mg)	The participants will receive assigned single dose of KN056 on Day 1
DRUG	KN056 (0.3mg)	The participants will receive assigned single dose of KN056 on Day 1
DRUG	KN056 (1.0mg)	The participants will receive assigned single dose of KN056 or placebo on Day 1
DRUG	KN056 (3.0mg)	The participants will receive assigned single dose of KN056 or placebo on Day 1
DRUG	KN056 (6.0mg)	The participants will receive assigned single dose of KN056 or placebo on Day 1
DRUG	KN056 (12.0mg)	The participants will receive assigned single dose of KN056 or placebo on Day 1
DRUG	KN056 (18.0mg)	The participants will receive assigned single dose of KN056 or placebo on Day 1

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-12-22
• Completion: 2024-02-29
• First posted: 2022-05-23
• Last updated: 2024-12-30

Locations

1 site across 1 country: New Zealand