A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DS-7011a

Placebo

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, DS-7011a

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female participants 18 to 45 years of age (inclusive), with a body mass index (BMI) of 18 kg/m^2 to 30 kg/m^2 (inclusive) at Screening.
Participants fully vaccinated against COVID-19 per current CDC guidelines or recovered from prior SARS-CoV-2 infection.
All women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
Women of childbearing potential must agree to use 2 different means of nonhormonal contraceptive methods.
Women of non-childbearing potential must be either:
- Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) or
- Naturally postmenopausal for at least 24 consecutive months prior to dosing, spontaneous cessation of menses, with a follicle-stimulating hormone (FSH) level at Screening of ≥40 mIU/mL.
Men must be surgically sterile (vasectomy 3 months before the dose of study drug) or agree to use approved contraception in addition to having their female partner (if of childbearing potential) use another acceptable form of contraception at any time during the study and for a period of 90 days after the dose of the study drug.
Males may not donate sperm during the study for a period of 90 days
Participants must be in overall good health, with no history of immunological and other chronic disorders, even if in remission and not requiring treatment.
Confirmed Japanese ethnicity (Stage 3 only)

Exclusion Criteria:

History or current chronic lung disease including asthma, COPD, or heavy smoking of >10 pack years
Previous or current treatment with systemic corticosteroids or any immunosuppressive agents
Participants who have received a transfusion or any blood products within the last year prior to dosing
Participants who have made a blood donation or have had a loss of blood ≥500 mL within 56 days prior to the dose of study drug
Participants who consume more than 28 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits) or those participants who have a significant history of alcoholism or drug/chemical abuse within the last 2 years
Participants with positive results on tests for drugs of abuse, cotinine, or alcohol at Screening and/or Day -1

Sites / Locations

Apex Clinical Research (Collaborative Neuroscience Research)
Worldwide Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DS-7011a

Placebo

Arm Description

Stage 1: Healthy participants who will be randomized to receive a single intravenous (IV) ascending dose of DS-7011a (starting dose 0.1 mg/kg). Stage 2: Healthy participants who will be randomized to receive a single subcutaneous (SC) ascending dose of DS-7011a (starting dose will be centered around estimated therapeutic dose confirmed in Stage 1). Stage 3: Healthy Japanese participants who will be randomized to receive an IV dose of DS-7011a (based on estimated therapeutic dose confirmed in Stage 1).

Healthy participants who will be randomized to receive a single dose of placebo.

Outcomes

Primary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants

Treatment-emergent adverse events (TEAEs) are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.

Secondary Outcome Measures

Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Healthy Participants

Area under the plasma concentration-time curve up to time t (AUCt), area under the plasma concentration-time curve up to infinity (AUCinf), and the percentage of AUCinf based on extrapolation (AUCextrap) will be calculated using noncompartmental methods.

Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Healthy Participants

Maximum concentration (Cmax) will be calculated using noncompartmental methods.

Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration Following Administration of DS-7011a in Healthy Participants

Time to reach maximum plasma concentration (Tmax) will be calculated using noncompartmental methods.

Pharmacokinetic Parameter Terminal Half-life Following Administration of DS-7011a in Healthy Participants

Terminal half-life (t1/2) will be calculated using noncompartmental methods.

Mean Interleukin (IL)-6 Levels Following Administration of DS-7011a in Healthy Participants

Mean IL-6 levels in whole blood stimulations will be assessed using ligand-activated toll-like receptor (TLR7) which stimulates IL-6 production.

Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA

Full Information

NCT ID

NCT05203692

First Posted

January 20, 2022

Last Updated

April 10, 2023

Sponsor

Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05203692

Brief Title

A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects

Official Title

A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

February 2, 2022 (Actual)

Primary Completion Date

January 25, 2023 (Actual)

Study Completion Date

March 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.

Detailed Description

This study will assess the safety, PK, and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of DS-7011a in healthy participants. This study will be conducted in 3 stages: Stage 1 - single ascending IV dose cohorts of DS-7011a (ie, up to 6 dose levels will be assessed starting at 0.1 mg/kg); Stage 2 - single ascending SC cohorts of DS-7011a (ie, up to 3 dose levels centered around the estimated therapeutic dose confirmed in Stage 1 will be assessed); and Stage 3 - a single IV cohort of DS-7011a in healthy participants of Japanese ethnicity (ie, 1 dose level at the estimated therapeutic dose as confirmed in Stage 1 will be assessed).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus, DS-7011a

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DS-7011a

Arm Type

Experimental

Arm Description

Stage 1: Healthy participants who will be randomized to receive a single intravenous (IV) ascending dose of DS-7011a (starting dose 0.1 mg/kg). Stage 2: Healthy participants who will be randomized to receive a single subcutaneous (SC) ascending dose of DS-7011a (starting dose will be centered around estimated therapeutic dose confirmed in Stage 1). Stage 3: Healthy Japanese participants who will be randomized to receive an IV dose of DS-7011a (based on estimated therapeutic dose confirmed in Stage 1).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Healthy participants who will be randomized to receive a single dose of placebo.

Intervention Type

Drug

Intervention Name(s)

DS-7011a

Intervention Description

Intravenous or subcutaneous administration, single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous or subcutaneous administration, single dose

Primary Outcome Measure Information:

Title

Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants

Description

Treatment-emergent adverse events (TEAEs) are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.

Time Frame

Screening (Day -28 to Day -7) up to Day 57 post-dose

Secondary Outcome Measure Information:

Title

Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Healthy Participants

Description

Area under the plasma concentration-time curve up to time t (AUCt), area under the plasma concentration-time curve up to infinity (AUCinf), and the percentage of AUCinf based on extrapolation (AUCextrap) will be calculated using noncompartmental methods.

Time Frame