# Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

> **NCT06776783** · PHASE3 · RECRUITING · sponsor: **Aerogen Pharma Limited** · enrollment: 520 (estimated)

## Conditions studied

- Respiratory Distress Syndrome
- Pre-term Infants

## Interventions

- **COMBINATION_PRODUCT:** APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
- **OTHER:** Control

## Key facts

- **NCT ID:** NCT06776783
- **Lead sponsor:** Aerogen Pharma Limited
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-09-24
- **Primary completion:** 2027-05
- **Final completion:** 2029-05
- **Target enrollment:** 520 (ESTIMATED)
- **Last updated:** 2026-04-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06776783

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06776783, "Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT06776783. Licensed CC0.

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