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A Study to Evaluate Effects of KN056 in Healthy Participants

NCT05385575 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Suzhou Alphamab Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Alexandra Cole · New Zealand Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2023-12-22
Completion
2024-02-29

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385575 on ClinicalTrials.gov