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First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

NCT07516639 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults.

This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose.

The main questions this study aims to answer are:

I. What medical problems (side effects) may occur after receiving ISH0613? How does ISH0613 move through and get processed in the body? II. Does ISH0613 affect certain biological markers related to the immune system? III. Researchers will compare ISH0613 to a placebo (a look-alike substance that contains no active drug) to better understand its effects.

Participants will:

I. Receive a single intravenous infusion of either ISH0613 or placebo II. Stay in the clinical unit for several days for close monitoring after dosing III. Return to the clinic for follow-up visits over several weeks IV. Provide blood samples for safety checks and laboratory testing V. Be monitored for any side effects throughout the study

Conditions

  • Healthy Subjects (HS)
  • SLE (Systemic Lupus)

Interventions

DRUG

ISH0613 for injection

80, 240, 480, 640 mg; i.v.

DRUG

Placebo

80, 240, 480, 640 mg; i.v.

Sponsors & Collaborators

  • SUNHO（China）BioPharmaceutical CO., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516639 on ClinicalTrials.gov