UMIN-CTR Clinical Trial

Basic information
Public title	A randomised, first-in-human, double-blinded, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CP1050 in healthy subjects; including the effect of food and gender on the pharmacokinetics and pharmacodynamics of a single dose of CP1050 in healthy subjects
Acronym	A randomised, first-in-human, double-blinded, placebo-controlled study of CP1050 in healthy subjects
Scientific Title	A randomised, first-in-human, double-blinded, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CP1050 in healthy subjects; including the effect of food and gender on the pharmacokinetics and pharmacodynamics of a single dose of CP1050 in healthy subjects
Scientific Title:Acronym	A randomised, first-in-human, double-blinded, placebo-controlled study of CP1050 in healthy subjects
Region	Europe

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and tolerability of single and multiple doses of CP1050 in healthy subjects
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	The primary safety endpoints are as follows: - incidence and severity of any drug-related adverse events - vital signs - clinical laboratory evaluations - 12-lead safety ECG - continuous (24-hour) ECG - pulmonary function test - ophthalmological assessments - physical examinations
Key secondary outcomes	The PK endpoints include: - AUClast - AUCinf - Cmax - Tmax - T1/2 The PD endpoints include absolute peripheral lymphocyte count and percentage change of baseline.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	CP1050 single oral dose
Interventions/Control_2	Placebo single oral dose
Interventions/Control_3	CP1050 oral repeated dose for 21 days
Interventions/Control_4	Placebo oral repeated dose for 21 days
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	55 years-old >=
Gender	Male and Female
Key inclusion criteria	- Caucasian males or females between 18 and 55 years of age (inclusive). - A body weight of >=60 kg for males and >=50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive). - Healthy and free from clinically significant illness or disease.
Key exclusion criteria	- Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator. - Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks. - Clinically significant abnormalities in ECG or laboratory tests.
Target sample size	116

Research contact person
Name of lead principal investigator	1st name Jim Middle name Last name Bush
Organization	Covance Clinical Research Unit (CRU) Ltd.
Division name	Clinical
Zip code	LS2 9LH
Address	Springfield House, Hyde Street, Leeds, LS2 9LH, United Kingdom
TEL	441133013644
Email	Jim.Bush@covance.com

Public contact
Name of contact person	1st name Tadaki Middle name Last name Sugawara
Organization	Curadim Pharma Co., Ltd.
Division name	Development Research Division
Zip code	100-0004
Address	Otemachi Financial City Grand Cube 3F, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
TEL	81342438654
Homepage URL
Email	info@curadim.co.jp

Sponsor
Institute	Curadim Pharma Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	North East - York Research Ethics Committee
Address	Jarrow Business Centre, Rolling Mill Road, Jarrow, Tyne & Wear, NE32 3DT United Kingdom
Tel	0207 104 8091
Email	nrescommittee.northeast-york@nhs.net

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Covance Clinical Research Unit (CRU) Ltd.

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	66
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 23 Day
Date of IRB	2018 Year 01 Month 17 Day
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date	2018 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 06 Day
Last modified on	2019 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035585