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

> **NCT07516639** · PHASE1 · NOT_YET_RECRUITING · sponsor: **SUNHO（China）BioPharmaceutical CO., Ltd.** · enrollment: 26 (estimated)

## Conditions studied

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

## Interventions

- **DRUG:** ISH0613 for injection
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT07516639
- **Lead sponsor:** SUNHO（China）BioPharmaceutical CO., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-04-01
- **Primary completion:** 2026-12-31
- **Final completion:** 2026-12-31
- **Target enrollment:** 26 (ESTIMATED)
- **Last updated:** 2026-04-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07516639

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07516639, "First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics". Retrieved via AI Analytics 2026-08-17 from https://api.ai-analytics.org/clinical/NCT07516639. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*