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

Phase 1

Waitlist Available

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Summary

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.

Eligible Conditions

Lupus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DS-7011aExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DS-7011a

2022

Completed Phase 1

~80

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