NCT04211415

Brief Summary

This is a phase 1, single-center, first-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male volunteers and Japanese participants with moderate to severe atopic dermatitis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

December 23, 2019

Last Update Submit

June 16, 2021

Conditions

Atopic Dermatitis

Keywords

Atopic DermatitisDS-2741a

Outcome Measures

Primary Outcomes (9)

  • Incidence of adverse events among participants receiving DS-2741a (Part 1 and Part 3)

    Day 1 through end of study, up to 4 weeks

  • Characterize pharmacokinetic parameter maximum plasma concentration (Cmax) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter time to reach maximum plasma concentration (Tmax) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter area under the curve from time 0 to last measurable time point (AUClast) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter area under the curve from time 0 to 168 h (AUC168h) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter total clearance (CL/F) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter area under the curve from time 0 to infinity (AUCinf) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter terminal elimination half-life (t1/2) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter volume of distribution (Vz/F) of plasma DS-2741a (Part 2)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

Secondary Outcomes (17)

  • Characterize pharmacokinetic parameter maximum plasma concentration (Cmax) of plasma DS-2741a (Part 1)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter time to reach maximum plasma concentration (Tmax) of plasma DS-2741a (Part 1)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter area under the curve from time 0 to last measurable time point (AUClast) of plasma DS-2741a (Part 1)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter area under the curve from time 0 to 168 h (AUC168h) of plasma DS-2741a (Part 1)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • Characterize pharmacokinetic parameter total clearance (CL/F) of plasma DS-2741a (Part 1)

    Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 11, Day 14, Day 17, Day 21, Day 28, Day 35, Day 42, Day 49

  • +12 more secondary outcomes

Study Arms (11)

Part 1: DS-2741a Cohort 1, 5 mg

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 5 mg.

Drug: DS-2741a

Part 1: DS-2741a Cohort 2, 15 mg

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 15 mg.

Drug: DS-2741a

Part 1: DS-2741a Cohort 3, 50 mg

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 50 mg.

Drug: DS-2741a

Part 1: DS-2741a Cohort 4, 150 mg

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 150 mg.

Drug: DS-2741a

Part 1: DS-2741a Cohort 5, 500 mg

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 500 mg.

Drug: DS-2741a

Part 1: DS-2741a Cohort 6, 1000 mg

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-2741a 1000 mg.

Drug: DS-2741a

Part 1: Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive a single, subcutaneous injection of placebo.

Drug: Placebo

Part 2: DS-2741a Cohort 1, X mg (based on results of Part 1)

EXPERIMENTAL

Participants will receive a single, subcutaneous injection of DS-2741a X mg, where X mg will be based on the maximum tolerated dose identified in Part 1.

Drug: DS-2741a

Part 2: DS-2741a Cohort 1, Y mg (based on results of Part 1)

EXPERIMENTAL

Participants will receive a single, subcutaneous injection of DS-2741a Y mg, where Y mg will be based on the maximum tolerated dose identified in Part 1.

Drug: DS-2741a

Part 3: DS-2741a Cohort 1, Z mg (based on results of Part 1)

EXPERIMENTAL

Participants will be randomized to receive a receive a single, subcutaneous injection of DS-2741a Z mg, where Z mg will be based on the maximum tolerated dose identified in Part 1.

Drug: DS-2741a

Part 3: Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive a single, subcutaneous injection of placebo.

Drug: Placebo

Interventions

DS-2741aDRUG

Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks

Part 1: DS-2741a Cohort 1, 5 mgPart 1: DS-2741a Cohort 2, 15 mgPart 1: DS-2741a Cohort 3, 50 mgPart 1: DS-2741a Cohort 4, 150 mgPart 1: DS-2741a Cohort 5, 500 mgPart 1: DS-2741a Cohort 6, 1000 mgPart 2: DS-2741a Cohort 1, X mg (based on results of Part 1)Part 2: DS-2741a Cohort 1, Y mg (based on results of Part 1)Part 3: DS-2741a Cohort 1, Z mg (based on results of Part 1)
PlaceboDRUG

Single, subcutaneous injection administered weekly for 4 weeks

Part 1: PlaceboPart 3: Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Part 1 and Part 3:
  • Japanese healthy male subjects.
  • Age ≥20 and ≤45 years upon providing informed consent.
  • Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening.
  • For Part 2:
  • Japanese Male or female, Age ≥20 upon providing informed consent.
  • Diagnosed with chronic atopic dermatitis (AD) at least 3 years before screening and by the criteria of Hannifin and Rajka at screening.

You may not qualify if:

  • For Part 1 and Part 3:
  • Having a history of atopic dermatitis
  • Having a history of hypersensitivity to drugs or other substances or being idiosyncratic
  • Having alcohol or drug dependence, etc.
  • For Part 2:
  • Having an active dermatological disease other than AD, which, in the investigator's opinion, would affect study assessments.
  • Having a history of serious disease in the study potentially endangering the participant, as judged by the investigator or sub-investigator.
  • Having a chronic or acute infection requiring treatment within 28 days before screening.
  • Having superficial skin infections within 7 days before screening.
  • Having a history of recurrent oral herpes and recurrent genital herpes.
  • Having a history of parasitic infection or invasive, opportunistic infection such as histoplasmosis despite infection resolution, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka Pharmacology Clinical Research Hospital

Osaka, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Clinical Study Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participant, care provider, investigator, and outcomes assessor will be blinded in Part 1 and Part 3 of the study. Part 2 of the study will be unblinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 26, 2019

Study Start

January 13, 2020

Primary Completion

March 14, 2020

Study Completion

December 18, 2020

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
More information

Locations

JP(1)