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

NCT05203692 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: DS7011-A-U101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; DS-7011a

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (6)

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

  Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57

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

  Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57

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

  Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57

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

  Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57

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

  Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57

Study Arms (2)

DS-7011a

EXPERIMENTAL

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).

Drug: DS-7011a

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DS-7011a DRUG

Intravenous or subcutaneous administration, single dose

DS-7011a

Placebo DRUG

Intravenous or subcutaneous administration, single dose

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (2)

Apex Clinical Research (Collaborative Neuroscience Research)

Long Beach, California, 90806, United States

Location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: January 24, 2022
• Study Start: February 2, 2022
• Primary Completion: January 25, 2023
• Study Completion: March 22, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)