A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers

Angitia Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Osteogenesis Imperfecta

Treatments: Drug: Placebo; Drug: AGA2115

Study type: Interventional

Funder types: Industry

Identifiers

NCT06086613

ACT22-002

Details and patient eligibility

About

To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women ≥18 to ≤65 years old.
• Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial.

Exclusion criteria

• History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day 1.
• Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed).
• Hyper- or hypocalcemia.
• Known sensitivity to mammalian-derived drug preparations and/or any biologics.
• Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

AGA2115

Experimental group

Description:

In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts.

Treatment:

Drug: AGA2115

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo.

Treatment:

Drug: Placebo