NCT05514340 Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
| NCT ID | NCT05514340 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pharmazz, Inc. |
| Condition | Hypoxic-Ischemic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-09-06 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-09-06 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.
Eligibility Criteria
Inclusion Criteria: 1. Either sex with ≥ 36 weeks of gestational age 2. Receiving supportive management for perinatal asphyxia 3. Perinatal depression, based on at least one of the following: * Apgar score of \<5 at 10 minutes * Need for resuscitation (chest compressions or mechanical ventilation) at birth * pH \<7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth * Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth. 4. Informed consent by one of the parents or a legal representative Exclusion Criteria: 1. Gestational age \<36 weeks 2. Admitted to hospital 12-hours after birth 3. A genetic or congenital condition that affects neuronal development 4. TORCH infection 5. Neonatal sepsis 6. Complex congenital heart disease 7. Severe dysmorphic feature 8. Microcephaly (head circumference \< 2 Standard Deviations below mean for gestational age)
Contact & Investigator
Anil Gulati
STUDY CHAIR
Chairman and CEO
Frequently Asked Questions
Who can join the NCT05514340 clinical trial?
This trial is open to participants of all sexes, studying Hypoxic-Ischemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05514340 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05514340 currently recruiting?
Yes, NCT05514340 is actively recruiting participants. Contact the research team at manish.lavhale@pharmazz.com for enrollment information.
Where is the NCT05514340 trial being conducted?
This trial is being conducted at Mangalore, India, Ludhiana, India, Hyderabad, India, Kanpur, India.
Who is sponsoring the NCT05514340 clinical trial?
NCT05514340 is sponsored by Pharmazz, Inc.. The principal investigator is Anil Gulati at Chairman and CEO. The trial plans to enroll 40 participants.