Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic Dermatitis

Phase 1TerminatedNCT04211415

Daiichi Sankyo Co., Ltd.8 enrolled

Overview

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.

This study consists of three parts. Part 1 and Part 3 are a single ascending and multiple dose study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male participants. Part 2 is a single-dose study to assess the pharmacokinetics, safety, pharmacodynamics and efficacy of DS-2741a after subcutaneous injection in Japanese participants with moderate to severe atopic dermatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

DS-2741aDRUG

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

PlaceboDRUG

Single, subcutaneous injection administered weekly for 4 weeks

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Osaka Pharmacology Clinical Research Hospital

Osaka, Japan

Outcomes

Primary Outcomes

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

Time frame: Day 1 through end of study, up to 4 weeks

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

Time frame: 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)

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

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

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

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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

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

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

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

Characterize pharmacokinetic parameter area under the curve from time 0 to infinity (AUCinf) of plasma DS-2741a (Part 1)

Time frame: 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 1)

Characterize pharmacokinetic parameter volume of distribution (Vz/F) of plasma DS-2741a (Part 1)

Incidence of anti-drug antibodies (ADAs) against DS-2741a (Part 1 and Part 2)

Time frame: Day 1 (pre-dose), Day 28, Day 49

Incidence of adverse events among participants receiving DS-2741a (Part 2)

Time frame: Day 1 through end of study, up to 4 weeks

Characterize pharmacokinetic parameter maximum plasma concentration (Cmax) of plasma DS-2741a (Part 3)

Time frame: Day 1 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 3, Day 5, Day 7 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 10, Day 12, Day 14 (pre-dose, 2, 8, 24, 36 hours after the start of administration), Day 17

Characterize pharmacokinetic parameter time to reach maximum plasma concentration (Tmax) of plasma DS-2741a (Part 3)

Characterize pharmacokinetic parameter trough plasma concentration (Ctrough) of plasma DS-2741a (Part 3)

Characterize pharmacokinetic parameter area under the curve from time 0 to 168 h (AUC168h) of plasma DS-2741a (Part 3)

Characterize pharmacokinetic parameter area under the curve from time 0 to tau (504-672 h) (AUCtau) of plasma DS-2741a (Part 3)

Characterize pharmacokinetic parameter terminal elimination half-life (t1/2) of plasma DS-2741a (Part 3)

Incidence of anti-drug antibodies (ADAs) against DS-2741a (Part 3)

Time frame: Day 1 (pre-dose),Day 7 (pre-dose), Day 14 (pre-dose), Day 21 (pre-dose), Day 49, Day 63