A Study of Subcutaneous KY1005 in Healthy Volunteers

NCT ID: NCT04449939

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2020-11-30

Brief Summary

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Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment.

Detailed Description

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Conditions

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Immune System Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after s.c. and i.v. administration, with i.v. KY1005 as a reference treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Single dose of KY1005 by i.v. infusion

Group Type EXPERIMENTAL

KY1005

Intervention Type DRUG

A human anti-OX40 ligand monoclonal antibody

Group 2

Single lower dose KY1005 by s.c. injection

Group Type EXPERIMENTAL

KY1005

Intervention Type DRUG

A human anti-OX40 ligand monoclonal antibody

Group 3

Single higher dose KY1005 by s.c. injections

Group Type EXPERIMENTAL

KY1005

Intervention Type DRUG

A human anti-OX40 ligand monoclonal antibody

Interventions

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KY1005

A human anti-OX40 ligand monoclonal antibody

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male, aged 18-45 years at screening
* Body weight 60-120 kg
* Body mass index (BMI) in the range 18.0-30.0 kg/m\^2 (inclusive)
* Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs and laboratory tests of blood and urine

Exclusion Criteria

* Clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive tests for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)
* Drug or alcohol abuse
* Use of over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
* Participation in other clinical trials of unlicensed medicines within the 3 months or 5 half-lives, whichever is longer, before admission to this study
* Loss of more than 400 mL blood, within the previous 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kymab Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeep Puri, MBBS JCPTGP MPhil

Role: PRINCIPAL_INVESTIGATOR

Hammersmith Medicines Research

Locations

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Hammersmith Medicines Research

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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KY1005-CT04

Identifier Type: -

Identifier Source: org_study_id

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