An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rezolute

Criteria

Inclusion Criteria:

• Male or female age 2-45 years old (except age 12-45 in US) with an established clinical diagnosis of congenital hyperinsulinism

• Able to provide written informed consent or, as applicable, assent

• Confirmed hypoglycemia as assessed by CGM, SMBG, and clinical evaluation, during Screening

• Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

• Out of range blood work for study entry

• Body Mass index outside of study entry criteria

• History of malignancy

• Clinically significant diseases, seropositivity for HIV, hepatitis B or C antibody

• Use of systemic corticosteroids within 30 days before Screening

• Known or suspected allergy to the study drug

• Recent use of an investigational drug or treatment, or participation in an investigational study

• Pregnant or lactating women

• History of drug abuse or excessive alcohol use