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

Recruiting at 1 trial location

Overseen By Contact for Clinical Trial Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Chronic lung disease, Alcoholism, others

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called DS-7011a in healthy people to see if it's safe and how it behaves in the body. Researchers will use different amounts of the drug to understand its effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used systemic corticosteroids or immunosuppressive agents. It's best to discuss your specific medications with the trial team.

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

Inclusion Criteria

Women of childbearing potential must agree to use 2 different means of nonhormonal contraceptive methods.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Stage 1 - Treatment

Single ascending intravenous (IV) dose cohorts of DS-7011a are administered to healthy participants

8 weeks

Multiple visits for dose administration and monitoring

Stage 2 - Treatment

Single ascending subcutaneous (SC) dose cohorts of DS-7011a are administered to healthy participants

8 weeks

Multiple visits for dose administration and monitoring

Stage 3 - Treatment

Single IV dose of DS-7011a is administered to healthy participants of Japanese ethnicity

8 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Regular follow-up visits

Treatment Details

Interventions

• DS-7011a

Participant Groups

Group I: DS-7011a Experimental Treatment 1 Intervention

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).

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University